{
"NDC": [
{
"NDCCode": "59088-165-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-165-54) ",
"NDC11Code": "59088-0165-54",
"ProductNDC": "59088-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrexyl Plus Iron",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200824",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM",
"StrengthNumber": "35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55",
"StrengthUnit": "ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200824",
"SamplePackage": "N",
"IndicationAndUsage": "Vitrexyl + Iron is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age.Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, alongwith a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well ascases of metabolic stress, and in convalescence.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: BHT, dicalcium phosphate, organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "71288-165-54",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-54) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52) ",
"NDC11Code": "71288-0165-54",
"ProductNDC": "71288-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nelarabine",
"NonProprietaryName": "Nelarabine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216038",
"LabelerName": "Meitheal Pharmaceuticals Inc",
"SubstanceName": "NELARABINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230110",
"SamplePackage": "N",
"IndicationAndUsage": "Nelarabine Injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.",
"Description": "Nelarabine Injection is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β-D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β-D-arabinofuranosyl-6-methoxy-9H-purine. It has the molecular formula C11H15N5O5and a molecular weight of 297.27. Nelarabine has the following structural formula. Nelarabine is slightly soluble in water and melts with decomposition between 209°C and 214°C. Nelarabine Injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride, USP (4.5 mg per mL) in Water for Injection, USP. Nelarabine Injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0."
},
{
"NDCCode": "59088-005-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-005-54) ",
"NDC11Code": "59088-0005-54",
"ProductNDC": "59088-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multitol-m",
"NonProprietaryName": "Multivitamin, Folate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE",
"StrengthNumber": "13.5; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 2040; 8; 200; 1500; 3; 25; 2.3",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"IndicationAndUsage": "Multitol-M is indicated to provide vitamins and minerals supplement to men and women. Folate is effective in the treatment of megaloblastic anemias due to a deficiency of folate (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as Retinyl Acetate)………………........ 1500 mcg RAE Vitamin C (as Ascorbic Acid) .………………..………...… 120 mg Vitamin D3 (As Cholecalciferol) ..……………….. 20 mcg (800 IU) Vitamin E (DL-alpha Tocopheryl Acetate) .……………….. 13.5 mg Thiamin (As Thiamine Mononitrate) …….………………..… 3 mg Riboflavin …………………………….….…..………….... 3.4 mg Niacin (as Niacinamide)…………………………………… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride)…………………. 20 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)………………………….. 8 mcg Calcium (as Calcium Carbonate)…………………………. 200 mg Magnesium (as Magnesium Oxide)……………………… 200 mg Zinc (as Zinc Oxide)……………………………………….. 25 mg Selenium (as Selenium Amino Acid Chelate)……………. 55 mcg Manganese (as Manganese Sulfate)……………………… 2.3 mg Chromium (as Chromium Polynicotinate)……………….. 35 mcg Molybdenum (as Molybdenum Amino Acid Chelate).……. 45 mcg Other Ingredients: Organic Cocoa Powder, Croscarmellose Sodium, Crospovidone, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Coating: (Hydroxypropyl Methylcellulose [HPMC], PEG-8)."
},
{
"NDCCode": "59088-008-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) ",
"NDC11Code": "59088-0008-54",
"ProductNDC": "59088-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finazol",
"NonProprietaryName": "Ferrous Fumarate, Folate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC CITRATE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 200; 10; 45; 3.25; 3.35; 22.5; 6; 1000; 26; 100; 15; 100; 18; 25; 50; 30; 30; 1; .75; 37.5; 25; 24.5; 25",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Finazol is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin A (as Retinyl Acetate) ……………………………….....1500 mcg RAE Vitamin C (as Ascorbic Acid) ….…..….…………………….……….....200 mg Vitamin D3 (as Cholecalciferol) ….…………………………....10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) ………………………….....45 mg Thiamin (as Thiamine Mononitrate) …..…..…………………………...3.25 mg Riboflavin (as Vitamin B2) …..…..…..…..………………………….…3.35 mg Niacin (as Niacinamide)……………………………………………..…22.5 mg Vitamin B6 (as Pyridoxine HCl)……………………………………………6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …………………1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)……………………………………..26 mcg Biotin………………………………………………………………….100 mcg Pantothenic Acid (as Calcium Pantothenate)………………………….....15 mg Calcium (as Calcium Carbonate)………………………………………..100 mg Iron (as Ferrous Fumarate)……………………………………………....18 mg Iodine (as Potassium Iodide)…………………………………………...25 mcg Magnesium (as Magnesium Oxide)……………………………………...50 mg Zinc (as Zinc Citrate)……………………………………………………..30 mg Selenium (as Selenomethionine)….…………………………………….30 mcg Copper (as Copper Oxide)………………………………………………....1 mg Manganese (as Manganese Sulfate)…………………………………...0.75 mg Chromium (as Chromium Polynicotinate)…………………………….37.5 mcg Molybdenum (as Sodium Molybdate)…………………………………..25 mcg Potassium (as Potassium Chloride) ……………………………….…..24.5 mg Boron (as Boron Citrate)……………………………………..…………25 mcg. Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide."
},
{
"NDCCode": "59088-009-54",
"PackageDescription": "30 TABLET in 1 BOTTLE (59088-009-54) ",
"NDC11Code": "59088-0009-54",
"ProductNDC": "59088-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatol-m",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240506",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLECALCIFEROL; FERROUS FUMARATE; MOLYBDENUM; ASCORBIC ACID; ZINC OXIDE; CHOLINE BITARTRATE; RIBOFLAVIN; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; VITAMIN A ACETATE; SELENIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CALCIUM CARBONATE; CHROMIUM NICOTINATE; MANGANESE SULFATE; POTASSIUM IODIDE; METHYLCOBALAMIN; LEVOMEFOLATE CALCIUM; THIAMINE MONONITRATE",
"StrengthNumber": "20; 27; 50; 120; 25; 55; 3.4; 200; 13.5; 1500; 70; 20; 50; 200; 45; 2.6; 150; 10; 2040; 3",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "Indications and Usage: Prenatol-M is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatol-M may be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Each caplet contains: Vitamin A (as Retinyl Acetate) ………………....… 1500 mcg RAE Vitamin C (as Ascorbic Acid) ………………….………… 120 mg Vitamin D3 (as Cholecalciferol).……………....... 20 mcg (800 IU) Vitamin E (as Dl-Alpha Tocopheryl Acetate) ….......….…. 13.5 mg Thiamin (as Thiamine Mononitrate) …………...…………… 3 mg Riboflavin ……………………….…………………….…. 3.4 mg Niacin (as Niacinamide) ………………..……………….… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride) …....…………... 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) ….... 2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin) ……….……………... 10 mcg Choline (as Choline Bitartrate) …….……………………… 55 mg Calcium (as Calcium Carbonate) ……...…………………. 200 mg Iron (as Ferrous Fumarate) ………..……………………… 27 mg Iodine (as Potassium Iodine) …...……………………….150 mcg Magnesium (as Magnesium Oxide) …...………………… 200 mg Zinc (as Zinc Oxide) ………………...…………………….. 25 mg Selenium (as Selenium Amino Acid Chelate) ……………. 70 mcg Manganese (as Manganese Sulfate) ……………………… 2.6 mg Chromium (as Chromium Polynicotinate) ……………….. 45 mcg Molybdenum (as Molybdenum Amino Acid Chelate)…...… 50 mcg."
},
{
"NDCCode": "59088-015-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-015-54) ",
"NDC11Code": "59088-0015-54",
"ProductNDC": "59088-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flotrex",
"NonProprietaryName": "Multivitamins, Sodium Fluoride 0.5 Mg",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250221",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250221",
"SamplePackage": "N",
"IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
"Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 0.5 mg. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
},
{
"NDCCode": "59088-017-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-017-54) ",
"NDC11Code": "59088-0017-54",
"ProductNDC": "59088-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flotrex",
"NonProprietaryName": "Multivitamins, Sodium Fluoride 0.25 Mg",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250319",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250319",
"SamplePackage": "N",
"IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
"Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid) ...................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ................................................................... 0.25 mg. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
},
{
"NDCCode": "59088-018-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-018-54) ",
"NDC11Code": "59088-0018-54",
"ProductNDC": "59088-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multivitamin",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN",
"StrengthNumber": "750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1000; 4.5",
"StrengthUnit": "ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.",
"Description": "Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE. Vitamin C (as Sodium Ascorbate and Ascorbic Acid).............. 60 mg. Vitamin D3 (as Cholecalciferol)............................................ 10 mcg. Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg. Thiamin (as Thiamine Mononitrate).................................... 1.05 mg. Riboflavin............................................................................... 1.2 mg. Niacin (as Niacinamide)....................................................... 13.5 mg. Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg. Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE. (1000 mcg as L-5-Methylfolate). Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg."
},
{
"NDCCode": "59088-020-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-020-54) ",
"NDC11Code": "59088-0020-54",
"ProductNDC": "59088-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flotrex",
"NonProprietaryName": "Multivitamins, Sodium Fluoride 1 Mg",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250710",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250710",
"SamplePackage": "N",
"IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
"Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 1 mg. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
},
{
"NDCCode": "59088-022-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-022-54) ",
"NDC11Code": "59088-0022-54",
"ProductNDC": "59088-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Boostervite",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FERROUS FUMARATE; PANTOTHENIC ACID; ORANGE JUICE; BIOTIN; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; THIAMINE MONONITRATE; PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; BROCCOLI SPROUT; PRUNUS CERASUS (BITTER CHERRY) FRUIT EXTRACT; KALE; WITHANIA SOMNIFERA ROOT",
"StrengthNumber": "18; 50; 2.5; 300; 10; 10; 100; 1000; 100; 10; 10; 10; 2.5; 2.5; 2.5; 60",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260619",
"SamplePackage": "N",
"IndicationAndUsage": "Boostervite contains a combination of vitamins, minerals, and botanical extracts intended to supplement nutritional intake in patients with low energy associated with nutritional needs, under the supervision of a healthcare provider.",
"Description": "Each Tablet Contains. Vitamin C (as ascorbic acid)……………….……………… 100 mg Vitamin D3 (as cholecalciferol)…………….……. 10 mcg (400 IU) Thiamin (as thiamine mononitrate)…………...……………. 10 mg Riboflavin ...................…………………………...………….. 10 mg Niacin (as niacinamide)…………………………....…………10 mg Vitamin B6 (as pyridoxine hydrochloride)………….……….10 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as methylcobalamin)………………….….... 100 mcg Biotin (as d-Biotin)……………………...…….................... 300 mcg Pantothenic Acid (as d-Calcium Pantothenate)………....… 50 mg Iron (as Ferrous Fumarate)……………………………......... 18 mg Withania somnifera (Ashwagandha) Root Powder….....…. 60 mg Brassica oleracea acephala (Kale) Powder……….…...…. 2.5 mg Brassica oleracea italica (Broccoli) Sprout Powder..…...... 2.5 mg Citrus sinensis (Orange) Juice Powder……....................... 2.5 mg Prunus cerasus (Tart Cherry) Extract................................. 2.5 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (vegetable source), Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol 400, Organic Maltodextrin, Organic Sunflower Lecithin, Organic Sunflower Oil, Organic Guar Gum)."
},
{
"NDCCode": "59088-078-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-078-54) ",
"NDC11Code": "59088-0078-54",
"ProductNDC": "59088-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Prenatol",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260821",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; .ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; CHOLINE BITARTRATE; FERROUS FUMARATE; POTASSIUM IODIDE",
"StrengthNumber": "3.4; 20; 120; 1000; 10; 200; 1500; 3; 25; 2.6; 30; 200; 45; 50; 50; 70; 20; 55; 27; 150",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260821",
"SamplePackage": "N",
"IndicationAndUsage": "PNV Prenatol TM is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PNV Prenatol TM may be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Each tablet contains. Vitamin A (as retinyl acetate)…………...1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)……………….………………. 120 mg Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (as Vitamin E)……….....……. 30 mg Thiamin (as thiamine mononitrate)…………...……………….3 mg Riboflavin.....................…………………………...…...……. 3.4 mg Niacin (as niacinamide)…………………………....………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)………….………..50 mg Folate (as l-5-methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as cyanocobalamin)………………….……….10 mcg. Choline (as choline bitartrate)..............................................55 mg Calcium (as calcium carbonate)……………………...……. 200 mg. Iron (as ferrous fumarate)...................................................27 mg. Iodine (as potassium iodide)............................................150 mcg Magnesium (as magnesium oxide)……………………...….200 mg Zinc (as zinc oxide)………………………………………....... 25 mg Selenium (as selenium amino acid chelate)……………….70 mcg Manganese (as manganese sulfate)………………………. 2.6 mg Chromium (as chromium polynicotinate)………………..... 45 mcg Molybdenum (as molybdenum amino acid chelate)……... 50 mcg. Other Ingredients:Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400)."
},
{
"NDCCode": "59088-090-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-090-54) ",
"NDC11Code": "59088-0090-54",
"ProductNDC": "59088-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Purefolix",
"NonProprietaryName": "Folic Acid, Vitamin D3",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151103",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FOLIC ACID; VITAMIN D",
"StrengthNumber": "1; 125",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151103",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "59088-128-54",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (59088-128-54) ",
"NDC11Code": "59088-0128-54",
"ProductNDC": "59088-128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Foliplus D",
"NonProprietaryName": "Folic Acid, Vitamin D3",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160715",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FOLIC ACID; VITAMIN D",
"StrengthNumber": "1; 83.325",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160715",
"SamplePackage": "N"
},
{
"NDCCode": "59088-139-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-139-54) ",
"NDC11Code": "59088-0139-54",
"ProductNDC": "59088-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitalux",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260603",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE",
"StrengthNumber": "200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260603",
"SamplePackage": "N",
"IndicationAndUsage": "Vitalux caplets are a prescription multivitamin formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed. Vitalux caplets may be beneficial in improving the nutritional status of women prior to conception.",
"Description": "DESCRIPTION:ACTIVE INGREDIENTS. Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)…………………………….........… 120 mg Vitamin D3 (as cholecalciferol)………………….......... 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (Vitamin E)……………...... 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………...........… 3 mg Riboflavin ..............................……………………………………. 3.4 mg Niacin (as niacinamide)………………………………...........…… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………........………. 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt )…. 1700 mcg DFE (1000 mcg L-Methylfolate) Vitamin B12 (as cyanocobalamin)………………........………… 10 mcg Choline (as choline bitartrate)………………………...........…….. 55 mg Calcium (as calcium carbonate)……………………..........……. 200 mg Iron (as ferrous fumarate)………………………………............… 27 mg Iodine (as potassium iodine)…………………………...........… 150 mcg Magnesium (as magnesium oxide)…………………..........…… 200 mg Zinc (as zinc oxide)…………………………………............…….. 25 mg Selenium (as selenium amino acid chelate)………......………. 70 mcg Manganese (as manganese sulfate)………………........……… 2.6 mg Chromium (as chromium polynicotinate)…………..........…….. 45 mcg Molybdenum (as molybdenum amino acid chelate)…......…… 50 mcg. OTHER INGREDIENTS: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400)."
},
{
"NDCCode": "59088-150-54",
"PackageDescription": "30 TABLET in 1 BOTTLE (59088-150-54) ",
"NDC11Code": "59088-0150-54",
"ProductNDC": "59088-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digenyx",
"NonProprietaryName": "Hyoscyamine Sulfate 0.125 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260513",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260513",
"SamplePackage": "N",
"IndicationAndUsage": "Digenyx (Hyoscyamine Sulfate USP, 0.125 mg) tablets are an anticholinergic agent used as adjunctive therapy for a range of gastrointestinal and genitourinary conditions. Hyoscyamine reduces gastrointestinal motility and secretions and relieves smooth muscle spasm. Digenyx (Hyoscyamine Sulfate USP, 0.125 mg) tablets may be used as adjunctive therapy in conditions such as: -Peptic ulcer disease -Irritable bowel syndrome and functional gastrointestinal disorders (e.g., spastic colon, mucous colitis) -Acute enterocolitis -Neurogenic bladder and bladder spasms -Biliary and renal colic (in combination with narcotic analgesics).",
"Description": "Digenyx (Hyoscyamine Sulfate USP, 0.125 mg) tablets are off-white to light beige round tablet containing 0.125 mg hyoscyamine sulfate formulated for oral administration. Each tablet also contains inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid, Sodium Starch Glycolate. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid,α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:."
},
{
"NDCCode": "59088-156-54",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (59088-156-54) ",
"NDC11Code": "59088-0156-54",
"ProductNDC": "59088-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Menatrol",
"NonProprietaryName": "Folate, Multivitamin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231218",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; RHUBARB; CALCIUM CARBONATE",
"StrengthNumber": "1.5; 600; 1000; 100; 4; 220",
"StrengthUnit": "mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231218",
"SamplePackage": "N",
"IndicationAndUsage": "For the dietary management of menopausal symptoms and the support of overall health during the menopausal phase.",
"Description": "Full Prescribing Information:Drug Description:Menatrol Capsules are a comprehensive dietary supplement tailored for individuals undergoing menopause. This specialized formulation offers a blend of vitamins, minerals, and plant extracts aiming to alleviate common menopausal symptoms:. Vitamin D3 (Cholecalciferol): Contained in a dose of 15 mcg (600 IU), Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Vitamin B6 (Pyridoxine Hydrochloride): At a dosage of 1.5 mg, Vitamin B6 is integral for mood stabilization and promoting energy. Typically, adults are advised to consume 1.3-2.0 mg per day. Always refer to the supplement label for specific dosages. Folate (L-5-Methyltetrahydrofolate calcium salt): Provided in a measure of 1700 mcg DFE (with 1000 mcg as L-5-Methylfolate), folate is pivotal for holistic health, potentially aiding in mood enhancement and energy regulation. An average adult dosage is between 400-800 mcg daily. Calcium (Calcium Carbonate): At a concentration of 220 mg, calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Oxide): Present in an amount of 100 mg, magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. On average, adults are recommended to consume 300-400 mg per day, though individual requirements can differ. Rhapontic Rhubarb: Rhapontic rhubarb (Rheum rhaponticum) is a natural ingredient that some women use to address menopausal symptoms, including hot flashes and mood swings. The appropriate dosage for this specific ingredient may vary, so consult the product label or a licensed healthcare practitioner for guidance. Each capsule contains: Vitamin D3 (as Cholecalciferol)....................................15 mcg (600 IU) Vitamin B6 (as Pyridoxine Hydrochloride)....................1.5 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)......1700 mcg DFE (1000 mcg as L-5-Methylfolate) Calcium (as Calcium Carbonate)..................................220 mg Magnesium (as Magnesium Oxide)..............................100 mg Rhapontic Rhubarb (Siberian Rhubarb) Root Extract...4 mg."
},
{
"NDCCode": "59088-158-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-158-54) ",
"NDC11Code": "59088-0158-54",
"ProductNDC": "59088-158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Davimet-m",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20231130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN",
"StrengthNumber": "750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1000; 4.5",
"StrengthUnit": "ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231130",
"SamplePackage": "N",
"IndicationAndUsage": "Davimet-M Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.",
"Description": "Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE Vitamin C (as Sodium Ascorbate & Ascorbic Acid).............. 60 mg Vitamin D3 (as Cholecalciferol)............................................ 10 mcg Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg Thiamin (as Thiamine Mononitrate).................................... 1.05 mg Riboflavin............................................................................... 1.2 mg Niacin (as Niacinamide)....................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg."
},
{
"NDCCode": "59088-160-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-160-54) ",
"NDC11Code": "59088-0160-54",
"ProductNDC": "59088-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Davimet With Iron",
"NonProprietaryName": "Iron, Folate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; CHOLECALCIFEROL; IRON; RIBOFLAVIN; METHYLCOBALAMIN; SODIUM ASCORBATE; LEVOMEFOLATE CALCIUM; .ALPHA.-TOCOPHEROL ACETATE, DL-",
"StrengthNumber": "750; 24; 13.5; 1.05; 1.05; 10; 11; 1.2; 4.5; 36; 1000; 6.75",
"StrengthUnit": "ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "Davimet with Iron Multivitamin Chewable Tablets are indicated for the treatment of iron deficiency anemia and folate deficiency, commonly seen in conditionssuch as extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. They are also indicated for condition in which irondeficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as casesof metabolic stress, and in convalescence.",
"Description": "Each caplet contains: Vitamin A (as Retinyl Acetate).......................................750 mcg RAE Vitamin C (as Sodium Ascorbate 36 mg and Ascorbic Acid 24 mg)........ 60 mg Vitamin D3 (as Cholecalciferol)................................. 10 mcg (400 IU) Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 6.75 mg Thiamin (as Thiamine Mononitrate)....................................... 1.05 mg Riboflavin................................................................................. 1.2 mg Niacin (as Niacinamide).......................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................. 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................................... 4.5 mcg Iron (as Iron Amino Acid Chelate)............................................... 11 mg. Other Ingredients: Aspartame, CI 15985 / [Yellow 6 Lake], Croscarmellose Sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural OrangeFlavor, Stearic Acid (Vegetable Source), Sucrose. Phenylketonurics: Phenylalanine 3.0 mg Per Tablet."
},
{
"NDCCode": "59088-162-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-162-54) ",
"NDC11Code": "59088-0162-54",
"ProductNDC": "59088-162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diatrol",
"NonProprietaryName": "Vitamins And Mineral",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240126",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "BIOTIN; VANADYL SULFATE; CHROMIUM NICOTINATE; GYMNEMA SYLVESTRE LEAF; ARGININE HYDROCHLORIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; PHYTONADIONE; VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; PANTOTHENIC ACID",
"StrengthNumber": "30; 15; 200; 100; 60; 13.5; 90; 900; 50; 18.75; 8; 4; 4; 24; 1000; 8; 8",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Increased Prothrombin Activity [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Reversed Anticoagulation Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240126",
"SamplePackage": "N",
"IndicationAndUsage": "Diatrol is indicated to provide significant amounts of essential vitamins and mineral. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.",
"Description": "Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE Vitamin C (as Ascorbic Acid)................................................. 50 mg Vitamin D3 (as Cholecalciferol)....................................... 18.75 mcg Vitamin E (as DL-Alpha Tocopheryl Acetate)...................... 13.5 mg Vitamin K1 (as Phytonadione)............................................. 90 mcg Thiamin (as Thiamine Mononitrate)......................................... 4 mg Riboflavin ................................................................................. 4 mg Niacin (as Niacinamide)......................................................... 24 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................... 8 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)........................................ 8 mcg Biotin (as D-biotin)............................................................... 30 mcg Pantothenic Acid ...................................................................... 8 mg Chromium (as Chromium Nicotinate)............................... 200 mcg Gymnema Sylvestre Leaf Powder........................................ 100 mg L-Arginine HCl...................................................................... 60 mcg Vanadyl Sulfate....................................................................... 15 mg."
},
{
"NDCCode": "59088-163-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-163-54) ",
"NDC11Code": "59088-0163-54",
"ProductNDC": "59088-163",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folixapure",
"NonProprietaryName": "Folic Acid, Vitamin D3",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200710",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FOLIC ACID; VITAMIN D",
"StrengthNumber": "1; 125",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200710",
"SamplePackage": "N",
"IndicationAndUsage": "Folixapure is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation. Folixapure can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.",
"Description": "Folixapure is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency. Folixapure should be administered under the supervision of a licensed medical practitioner. Each tablet contains: Folic Acid ..........................................................................1700 mcg DFE. (1000 mcg folic acid) Vitamin D 3 (cholecalciferol) ......................................125 mcg. 5000 IU. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, stearic acid, magnesium stearate."
},
{
"NDCCode": "59088-164-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-164-54) ",
"NDC11Code": "59088-0164-54",
"ProductNDC": "59088-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrexyl",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200829",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE",
"StrengthNumber": "30; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 1000; 8; 200; 1500; 3; 25; 2.3",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200829",
"SamplePackage": "N",
"IndicationAndUsage": "Vitrexyl is indicated to provide vitamin supplement to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)……………. 30 mg (30IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-166-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-166-54) ",
"NDC11Code": "59088-0166-54",
"ProductNDC": "59088-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatrix",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200829",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; CHROMIUM NICOTINATE; SELENIUM; POTASSIUM IODIDE; MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE",
"StrengthNumber": "27; 25; 50; 55; 45; 70; 150; 200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200829",
"SamplePackage": "N",
"IndicationAndUsage": "Prenatrix is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatrix may be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Active ingredients: Each caplet contains:. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as Choline Bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: BHT, dicalcium phosphate, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-167-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-167-54) ",
"NDC11Code": "59088-0167-54",
"ProductNDC": "59088-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrexate",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE",
"StrengthNumber": "30; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 1000; 8; 200; 1500; 3; 25; 2.3",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-168-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-168-54) ",
"NDC11Code": "59088-0168-54",
"ProductNDC": "59088-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrexate Fe",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM",
"StrengthNumber": "35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55",
"StrengthUnit": "ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "Vitrexate FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age.Also for the treatment of a condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-169-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-169-54) ",
"NDC11Code": "59088-0169-54",
"ProductNDC": "59088-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatryl",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE",
"StrengthNumber": "200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "Indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. May be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Full Prescribing Information. Active ingredient: Each caplet contains:. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as choline bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-170-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-170-54) ",
"NDC11Code": "59088-0170-54",
"ProductNDC": "59088-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Davimet With Fluoride",
"NonProprietaryName": "Multivitamin, Fluoride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20240228",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN",
"StrengthNumber": ".75; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 1000; 4.5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240228",
"SamplePackage": "N",
"IndicationAndUsage": "Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Davimet with Flouride 0.75 mg Chewable Multivitamin provide 0.75 mg fluoride in tablet form for children 6-16 years of age in areas where the drinking water fluoride level is less than 0.3 ppm. Davimet with Flouride 0.75 mg Chewable Multivitamin supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. Children using Davimet with Flouride 0.75 mg Chewable Multivitamin regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Davimet with Flouride 0.75 mg Chewable Multivitamin is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.",
"Description": "Each Chewable Tablet Contains: Vitamin A (as Retinyl Acetate)............................................. 750 mcg RAE Vitamin C (as Sodium Ascorbate 36 mg and Ascorbic Acid 24 mg)............... 60 mg Vitamin D3 (as Cholecalciferol)......................................... 10 mcg (400IU) Vitamin E (as DL-Alpha Tocopheryl Acetate)............................... 6.75 mg Thiamin (as Thiamine Mononitrate)............................................. 1.05 mg Riboflavin...................................................................................... 1.2 mg Niacin (as Niacinamide)............................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride)................................... 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)........…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin).............................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................... 0.75 mg. Davimet with Flouride 0.75 mg Chewable Multivitamin active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Davimet with Flouride 0.75 mg Chewable Multivitamin provide sodium fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Natural Grape Flavor, Magnesium Stearate (Vegetable Source), Maltodextrin, Microcrystalline Cellulose, Stearic Acid (Vegetable Source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
},
{
"NDCCode": "59088-171-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-171-54) ",
"NDC11Code": "59088-0171-54",
"ProductNDC": "59088-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitranol",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE; SELENIUM; FOLIC ACID; MAGNESIUM OXIDE; MOLYBDENUM; THIAMINE MONONITRATE; CYANOCOBALAMIN; VITAMIN A ACETATE; CHROMIUM NICOTINATE; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; ZINC OXIDE; CALCIUM CARBONATE; ASCORBIC ACID; MANGANESE SULFATE",
"StrengthNumber": "20; 55; 1000; 200; 45; 3; 8; 1500; 35; 20; 3.4; 20; 30; 25; 200; 120; 2.3",
"StrengthUnit": "mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210111",
"SamplePackage": "N",
"IndicationAndUsage": "To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-172-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-172-54) ",
"NDC11Code": "59088-0172-54",
"ProductNDC": "59088-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prometa",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE",
"StrengthNumber": "200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210111",
"SamplePackage": "N",
"IndicationAndUsage": "Indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. May be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Full Prescribing Information. Active ingredient: Each caplet contains:. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as choline bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-173-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-173-54) ",
"NDC11Code": "59088-0173-54",
"ProductNDC": "59088-173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitranol Fe",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM",
"StrengthNumber": "35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55",
"StrengthUnit": "ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N",
"IndicationAndUsage": "Vitranol FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)…………………………. 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venexa",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210129",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE",
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"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
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"IndicationAndUsage": "Venexa is indicated to provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8)."
}
]
}
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<ProductNDC>59088-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrexyl Plus Iron</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200824</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM</SubstanceName>
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<Description>Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: BHT, dicalcium phosphate, organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
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<NDC>
<NDCCode>71288-165-54</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-54) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52) </PackageDescription>
<NDC11Code>71288-0165-54</NDC11Code>
<ProductNDC>71288-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nelarabine</ProprietaryName>
<NonProprietaryName>Nelarabine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216038</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc</LabelerName>
<SubstanceName>NELARABINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nelarabine Injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.</IndicationAndUsage>
<Description>Nelarabine Injection is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β-D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β-D-arabinofuranosyl-6-methoxy-9H-purine. It has the molecular formula C11H15N5O5and a molecular weight of 297.27. Nelarabine has the following structural formula. Nelarabine is slightly soluble in water and melts with decomposition between 209°C and 214°C. Nelarabine Injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride, USP (4.5 mg per mL) in Water for Injection, USP. Nelarabine Injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.</Description>
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<NDC>
<NDCCode>59088-005-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-005-54) </PackageDescription>
<NDC11Code>59088-0005-54</NDC11Code>
<ProductNDC>59088-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multitol-m</ProprietaryName>
<NonProprietaryName>Multivitamin, Folate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>13.5; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 2040; 8; 200; 1500; 3; 25; 2.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Multitol-M is indicated to provide vitamins and minerals supplement to men and women. Folate is effective in the treatment of megaloblastic anemias due to a deficiency of folate (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as Retinyl Acetate)………………........ 1500 mcg RAE Vitamin C (as Ascorbic Acid) .………………..………...… 120 mg Vitamin D3 (As Cholecalciferol) ..……………….. 20 mcg (800 IU) Vitamin E (DL-alpha Tocopheryl Acetate) .……………….. 13.5 mg Thiamin (As Thiamine Mononitrate) …….………………..… 3 mg Riboflavin …………………………….….…..………….... 3.4 mg Niacin (as Niacinamide)…………………………………… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride)…………………. 20 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)………………………….. 8 mcg Calcium (as Calcium Carbonate)…………………………. 200 mg Magnesium (as Magnesium Oxide)……………………… 200 mg Zinc (as Zinc Oxide)……………………………………….. 25 mg Selenium (as Selenium Amino Acid Chelate)……………. 55 mcg Manganese (as Manganese Sulfate)……………………… 2.3 mg Chromium (as Chromium Polynicotinate)……………….. 35 mcg Molybdenum (as Molybdenum Amino Acid Chelate).……. 45 mcg Other Ingredients: Organic Cocoa Powder, Croscarmellose Sodium, Crospovidone, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Coating: (Hydroxypropyl Methylcellulose [HPMC], PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-008-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) </PackageDescription>
<NDC11Code>59088-0008-54</NDC11Code>
<ProductNDC>59088-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finazol</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241011</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC CITRATE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 200; 10; 45; 3.25; 3.35; 22.5; 6; 1000; 26; 100; 15; 100; 18; 25; 50; 30; 30; 1; .75; 37.5; 25; 24.5; 25</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finazol is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin A (as Retinyl Acetate) ……………………………….....1500 mcg RAE Vitamin C (as Ascorbic Acid) ….…..….…………………….……….....200 mg Vitamin D3 (as Cholecalciferol) ….…………………………....10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) ………………………….....45 mg Thiamin (as Thiamine Mononitrate) …..…..…………………………...3.25 mg Riboflavin (as Vitamin B2) …..…..…..…..………………………….…3.35 mg Niacin (as Niacinamide)……………………………………………..…22.5 mg Vitamin B6 (as Pyridoxine HCl)……………………………………………6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …………………1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)……………………………………..26 mcg Biotin………………………………………………………………….100 mcg Pantothenic Acid (as Calcium Pantothenate)………………………….....15 mg Calcium (as Calcium Carbonate)………………………………………..100 mg Iron (as Ferrous Fumarate)……………………………………………....18 mg Iodine (as Potassium Iodide)…………………………………………...25 mcg Magnesium (as Magnesium Oxide)……………………………………...50 mg Zinc (as Zinc Citrate)……………………………………………………..30 mg Selenium (as Selenomethionine)….…………………………………….30 mcg Copper (as Copper Oxide)………………………………………………....1 mg Manganese (as Manganese Sulfate)…………………………………...0.75 mg Chromium (as Chromium Polynicotinate)…………………………….37.5 mcg Molybdenum (as Sodium Molybdate)…………………………………..25 mcg Potassium (as Potassium Chloride) ……………………………….…..24.5 mg Boron (as Boron Citrate)……………………………………..…………25 mcg. Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59088-009-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59088-009-54) </PackageDescription>
<NDC11Code>59088-0009-54</NDC11Code>
<ProductNDC>59088-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatol-m</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240506</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLECALCIFEROL; FERROUS FUMARATE; MOLYBDENUM; ASCORBIC ACID; ZINC OXIDE; CHOLINE BITARTRATE; RIBOFLAVIN; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; VITAMIN A ACETATE; SELENIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CALCIUM CARBONATE; CHROMIUM NICOTINATE; MANGANESE SULFATE; POTASSIUM IODIDE; METHYLCOBALAMIN; LEVOMEFOLATE CALCIUM; THIAMINE MONONITRATE</SubstanceName>
<StrengthNumber>20; 27; 50; 120; 25; 55; 3.4; 200; 13.5; 1500; 70; 20; 50; 200; 45; 2.6; 150; 10; 2040; 3</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications and Usage: Prenatol-M is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatol-M may be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Each caplet contains: Vitamin A (as Retinyl Acetate) ………………....… 1500 mcg RAE Vitamin C (as Ascorbic Acid) ………………….………… 120 mg Vitamin D3 (as Cholecalciferol).……………....... 20 mcg (800 IU) Vitamin E (as Dl-Alpha Tocopheryl Acetate) ….......….…. 13.5 mg Thiamin (as Thiamine Mononitrate) …………...…………… 3 mg Riboflavin ……………………….…………………….…. 3.4 mg Niacin (as Niacinamide) ………………..……………….… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride) …....…………... 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) ….... 2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin) ……….……………... 10 mcg Choline (as Choline Bitartrate) …….……………………… 55 mg Calcium (as Calcium Carbonate) ……...…………………. 200 mg Iron (as Ferrous Fumarate) ………..……………………… 27 mg Iodine (as Potassium Iodine) …...……………………….150 mcg Magnesium (as Magnesium Oxide) …...………………… 200 mg Zinc (as Zinc Oxide) ………………...…………………….. 25 mg Selenium (as Selenium Amino Acid Chelate) ……………. 70 mcg Manganese (as Manganese Sulfate) ……………………… 2.6 mg Chromium (as Chromium Polynicotinate) ……………….. 45 mcg Molybdenum (as Molybdenum Amino Acid Chelate)…...… 50 mcg.</Description>
</NDC>
<NDC>
<NDCCode>59088-015-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-015-54) </PackageDescription>
<NDC11Code>59088-0015-54</NDC11Code>
<ProductNDC>59088-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flotrex</ProprietaryName>
<NonProprietaryName>Multivitamins, Sodium Fluoride 0.5 Mg</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250221</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
<Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 0.5 mg. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>59088-017-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-017-54) </PackageDescription>
<NDC11Code>59088-0017-54</NDC11Code>
<ProductNDC>59088-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flotrex</ProprietaryName>
<NonProprietaryName>Multivitamins, Sodium Fluoride 0.25 Mg</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250319</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
<Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid) ...................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ................................................................... 0.25 mg. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>59088-018-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-018-54) </PackageDescription>
<NDC11Code>59088-0018-54</NDC11Code>
<ProductNDC>59088-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN</SubstanceName>
<StrengthNumber>750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1000; 4.5</StrengthNumber>
<StrengthUnit>ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.</IndicationAndUsage>
<Description>Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE. Vitamin C (as Sodium Ascorbate and Ascorbic Acid).............. 60 mg. Vitamin D3 (as Cholecalciferol)............................................ 10 mcg. Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg. Thiamin (as Thiamine Mononitrate).................................... 1.05 mg. Riboflavin............................................................................... 1.2 mg. Niacin (as Niacinamide)....................................................... 13.5 mg. Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg. Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE. (1000 mcg as L-5-Methylfolate). Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg.</Description>
</NDC>
<NDC>
<NDCCode>59088-020-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-020-54) </PackageDescription>
<NDC11Code>59088-0020-54</NDC11Code>
<ProductNDC>59088-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flotrex</ProprietaryName>
<NonProprietaryName>Multivitamins, Sodium Fluoride 1 Mg</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
<Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 1 mg. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>59088-022-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-022-54) </PackageDescription>
<NDC11Code>59088-0022-54</NDC11Code>
<ProductNDC>59088-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Boostervite</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; PANTOTHENIC ACID; ORANGE JUICE; BIOTIN; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; THIAMINE MONONITRATE; PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; BROCCOLI SPROUT; PRUNUS CERASUS (BITTER CHERRY) FRUIT EXTRACT; KALE; WITHANIA SOMNIFERA ROOT</SubstanceName>
<StrengthNumber>18; 50; 2.5; 300; 10; 10; 100; 1000; 100; 10; 10; 10; 2.5; 2.5; 2.5; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Boostervite contains a combination of vitamins, minerals, and botanical extracts intended to supplement nutritional intake in patients with low energy associated with nutritional needs, under the supervision of a healthcare provider.</IndicationAndUsage>
<Description>Each Tablet Contains. Vitamin C (as ascorbic acid)……………….……………… 100 mg Vitamin D3 (as cholecalciferol)…………….……. 10 mcg (400 IU) Thiamin (as thiamine mononitrate)…………...……………. 10 mg Riboflavin ...................…………………………...………….. 10 mg Niacin (as niacinamide)…………………………....…………10 mg Vitamin B6 (as pyridoxine hydrochloride)………….……….10 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as methylcobalamin)………………….….... 100 mcg Biotin (as d-Biotin)……………………...…….................... 300 mcg Pantothenic Acid (as d-Calcium Pantothenate)………....… 50 mg Iron (as Ferrous Fumarate)……………………………......... 18 mg Withania somnifera (Ashwagandha) Root Powder….....…. 60 mg Brassica oleracea acephala (Kale) Powder……….…...…. 2.5 mg Brassica oleracea italica (Broccoli) Sprout Powder..…...... 2.5 mg Citrus sinensis (Orange) Juice Powder……....................... 2.5 mg Prunus cerasus (Tart Cherry) Extract................................. 2.5 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (vegetable source), Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol 400, Organic Maltodextrin, Organic Sunflower Lecithin, Organic Sunflower Oil, Organic Guar Gum).</Description>
</NDC>
<NDC>
<NDCCode>59088-078-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-078-54) </PackageDescription>
<NDC11Code>59088-0078-54</NDC11Code>
<ProductNDC>59088-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatol</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260821</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; .ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; CHOLINE BITARTRATE; FERROUS FUMARATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>3.4; 20; 120; 1000; 10; 200; 1500; 3; 25; 2.6; 30; 200; 45; 50; 50; 70; 20; 55; 27; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PNV Prenatol TM is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PNV Prenatol TM may be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Each tablet contains. Vitamin A (as retinyl acetate)…………...1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)……………….………………. 120 mg Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (as Vitamin E)……….....……. 30 mg Thiamin (as thiamine mononitrate)…………...……………….3 mg Riboflavin.....................…………………………...…...……. 3.4 mg Niacin (as niacinamide)…………………………....………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)………….………..50 mg Folate (as l-5-methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as cyanocobalamin)………………….……….10 mcg. Choline (as choline bitartrate)..............................................55 mg Calcium (as calcium carbonate)……………………...……. 200 mg. Iron (as ferrous fumarate)...................................................27 mg. Iodine (as potassium iodide)............................................150 mcg Magnesium (as magnesium oxide)……………………...….200 mg Zinc (as zinc oxide)………………………………………....... 25 mg Selenium (as selenium amino acid chelate)……………….70 mcg Manganese (as manganese sulfate)………………………. 2.6 mg Chromium (as chromium polynicotinate)………………..... 45 mcg Molybdenum (as molybdenum amino acid chelate)……... 50 mcg. Other Ingredients:Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400).</Description>
</NDC>
<NDC>
<NDCCode>59088-090-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-090-54) </PackageDescription>
<NDC11Code>59088-0090-54</NDC11Code>
<ProductNDC>59088-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Purefolix</ProprietaryName>
<NonProprietaryName>Folic Acid, Vitamin D3</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151103</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FOLIC ACID; VITAMIN D</SubstanceName>
<StrengthNumber>1; 125</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151103</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-128-54</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (59088-128-54) </PackageDescription>
<NDC11Code>59088-0128-54</NDC11Code>
<ProductNDC>59088-128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Foliplus D</ProprietaryName>
<NonProprietaryName>Folic Acid, Vitamin D3</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160715</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FOLIC ACID; VITAMIN D</SubstanceName>
<StrengthNumber>1; 83.325</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-139-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-139-54) </PackageDescription>
<NDC11Code>59088-0139-54</NDC11Code>
<ProductNDC>59088-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitalux</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260603</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitalux caplets are a prescription multivitamin formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed. Vitalux caplets may be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>DESCRIPTION:ACTIVE INGREDIENTS. Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)…………………………….........… 120 mg Vitamin D3 (as cholecalciferol)………………….......... 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (Vitamin E)……………...... 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………...........… 3 mg Riboflavin ..............................……………………………………. 3.4 mg Niacin (as niacinamide)………………………………...........…… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………........………. 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt )…. 1700 mcg DFE (1000 mcg L-Methylfolate) Vitamin B12 (as cyanocobalamin)………………........………… 10 mcg Choline (as choline bitartrate)………………………...........…….. 55 mg Calcium (as calcium carbonate)……………………..........……. 200 mg Iron (as ferrous fumarate)………………………………............… 27 mg Iodine (as potassium iodine)…………………………...........… 150 mcg Magnesium (as magnesium oxide)…………………..........…… 200 mg Zinc (as zinc oxide)…………………………………............…….. 25 mg Selenium (as selenium amino acid chelate)………......………. 70 mcg Manganese (as manganese sulfate)………………........……… 2.6 mg Chromium (as chromium polynicotinate)…………..........…….. 45 mcg Molybdenum (as molybdenum amino acid chelate)…......…… 50 mcg. OTHER INGREDIENTS: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400).</Description>
</NDC>
<NDC>
<NDCCode>59088-150-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59088-150-54) </PackageDescription>
<NDC11Code>59088-0150-54</NDC11Code>
<ProductNDC>59088-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digenyx</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate 0.125 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260513</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digenyx (Hyoscyamine Sulfate USP, 0.125 mg) tablets are an anticholinergic agent used as adjunctive therapy for a range of gastrointestinal and genitourinary conditions. Hyoscyamine reduces gastrointestinal motility and secretions and relieves smooth muscle spasm. Digenyx (Hyoscyamine Sulfate USP, 0.125 mg) tablets may be used as adjunctive therapy in conditions such as: -Peptic ulcer disease -Irritable bowel syndrome and functional gastrointestinal disorders (e.g., spastic colon, mucous colitis) -Acute enterocolitis -Neurogenic bladder and bladder spasms -Biliary and renal colic (in combination with narcotic analgesics).</IndicationAndUsage>
<Description>Digenyx (Hyoscyamine Sulfate USP, 0.125 mg) tablets are off-white to light beige round tablet containing 0.125 mg hyoscyamine sulfate formulated for oral administration. Each tablet also contains inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid, Sodium Starch Glycolate. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid,α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>59088-156-54</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (59088-156-54) </PackageDescription>
<NDC11Code>59088-0156-54</NDC11Code>
<ProductNDC>59088-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Menatrol</ProprietaryName>
<NonProprietaryName>Folate, Multivitamin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; RHUBARB; CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1.5; 600; 1000; 100; 4; 220</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the dietary management of menopausal symptoms and the support of overall health during the menopausal phase.</IndicationAndUsage>
<Description>Full Prescribing Information:Drug Description:Menatrol Capsules are a comprehensive dietary supplement tailored for individuals undergoing menopause. This specialized formulation offers a blend of vitamins, minerals, and plant extracts aiming to alleviate common menopausal symptoms:. Vitamin D3 (Cholecalciferol): Contained in a dose of 15 mcg (600 IU), Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Vitamin B6 (Pyridoxine Hydrochloride): At a dosage of 1.5 mg, Vitamin B6 is integral for mood stabilization and promoting energy. Typically, adults are advised to consume 1.3-2.0 mg per day. Always refer to the supplement label for specific dosages. Folate (L-5-Methyltetrahydrofolate calcium salt): Provided in a measure of 1700 mcg DFE (with 1000 mcg as L-5-Methylfolate), folate is pivotal for holistic health, potentially aiding in mood enhancement and energy regulation. An average adult dosage is between 400-800 mcg daily. Calcium (Calcium Carbonate): At a concentration of 220 mg, calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Oxide): Present in an amount of 100 mg, magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. On average, adults are recommended to consume 300-400 mg per day, though individual requirements can differ. Rhapontic Rhubarb: Rhapontic rhubarb (Rheum rhaponticum) is a natural ingredient that some women use to address menopausal symptoms, including hot flashes and mood swings. The appropriate dosage for this specific ingredient may vary, so consult the product label or a licensed healthcare practitioner for guidance. Each capsule contains: Vitamin D3 (as Cholecalciferol)....................................15 mcg (600 IU) Vitamin B6 (as Pyridoxine Hydrochloride)....................1.5 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)......1700 mcg DFE (1000 mcg as L-5-Methylfolate) Calcium (as Calcium Carbonate)..................................220 mg Magnesium (as Magnesium Oxide)..............................100 mg Rhapontic Rhubarb (Siberian Rhubarb) Root Extract...4 mg.</Description>
</NDC>
<NDC>
<NDCCode>59088-158-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-158-54) </PackageDescription>
<NDC11Code>59088-0158-54</NDC11Code>
<ProductNDC>59088-158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Davimet-m</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231130</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN</SubstanceName>
<StrengthNumber>750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1000; 4.5</StrengthNumber>
<StrengthUnit>ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Davimet-M Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.</IndicationAndUsage>
<Description>Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE Vitamin C (as Sodium Ascorbate & Ascorbic Acid).............. 60 mg Vitamin D3 (as Cholecalciferol)............................................ 10 mcg Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg Thiamin (as Thiamine Mononitrate).................................... 1.05 mg Riboflavin............................................................................... 1.2 mg Niacin (as Niacinamide)....................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg.</Description>
</NDC>
<NDC>
<NDCCode>59088-160-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-160-54) </PackageDescription>
<NDC11Code>59088-0160-54</NDC11Code>
<ProductNDC>59088-160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Davimet With Iron</ProprietaryName>
<NonProprietaryName>Iron, Folate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; CHOLECALCIFEROL; IRON; RIBOFLAVIN; METHYLCOBALAMIN; SODIUM ASCORBATE; LEVOMEFOLATE CALCIUM; .ALPHA.-TOCOPHEROL ACETATE, DL-</SubstanceName>
<StrengthNumber>750; 24; 13.5; 1.05; 1.05; 10; 11; 1.2; 4.5; 36; 1000; 6.75</StrengthNumber>
<StrengthUnit>ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Davimet with Iron Multivitamin Chewable Tablets are indicated for the treatment of iron deficiency anemia and folate deficiency, commonly seen in conditionssuch as extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. They are also indicated for condition in which irondeficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as casesof metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Each caplet contains: Vitamin A (as Retinyl Acetate).......................................750 mcg RAE Vitamin C (as Sodium Ascorbate 36 mg and Ascorbic Acid 24 mg)........ 60 mg Vitamin D3 (as Cholecalciferol)................................. 10 mcg (400 IU) Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 6.75 mg Thiamin (as Thiamine Mononitrate)....................................... 1.05 mg Riboflavin................................................................................. 1.2 mg Niacin (as Niacinamide).......................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................. 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................................... 4.5 mcg Iron (as Iron Amino Acid Chelate)............................................... 11 mg. Other Ingredients: Aspartame, CI 15985 / [Yellow 6 Lake], Croscarmellose Sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural OrangeFlavor, Stearic Acid (Vegetable Source), Sucrose. Phenylketonurics: Phenylalanine 3.0 mg Per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>59088-162-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-162-54) </PackageDescription>
<NDC11Code>59088-0162-54</NDC11Code>
<ProductNDC>59088-162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diatrol</ProprietaryName>
<NonProprietaryName>Vitamins And Mineral</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240126</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>BIOTIN; VANADYL SULFATE; CHROMIUM NICOTINATE; GYMNEMA SYLVESTRE LEAF; ARGININE HYDROCHLORIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; PHYTONADIONE; VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; PANTOTHENIC ACID</SubstanceName>
<StrengthNumber>30; 15; 200; 100; 60; 13.5; 90; 900; 50; 18.75; 8; 4; 4; 24; 1000; 8; 8</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Increased Prothrombin Activity [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Reversed Anticoagulation Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diatrol is indicated to provide significant amounts of essential vitamins and mineral. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.</IndicationAndUsage>
<Description>Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE Vitamin C (as Ascorbic Acid)................................................. 50 mg Vitamin D3 (as Cholecalciferol)....................................... 18.75 mcg Vitamin E (as DL-Alpha Tocopheryl Acetate)...................... 13.5 mg Vitamin K1 (as Phytonadione)............................................. 90 mcg Thiamin (as Thiamine Mononitrate)......................................... 4 mg Riboflavin ................................................................................. 4 mg Niacin (as Niacinamide)......................................................... 24 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................... 8 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)........................................ 8 mcg Biotin (as D-biotin)............................................................... 30 mcg Pantothenic Acid ...................................................................... 8 mg Chromium (as Chromium Nicotinate)............................... 200 mcg Gymnema Sylvestre Leaf Powder........................................ 100 mg L-Arginine HCl...................................................................... 60 mcg Vanadyl Sulfate....................................................................... 15 mg.</Description>
</NDC>
<NDC>
<NDCCode>59088-163-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-163-54) </PackageDescription>
<NDC11Code>59088-0163-54</NDC11Code>
<ProductNDC>59088-163</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folixapure</ProprietaryName>
<NonProprietaryName>Folic Acid, Vitamin D3</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FOLIC ACID; VITAMIN D</SubstanceName>
<StrengthNumber>1; 125</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folixapure is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation. Folixapure can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.</IndicationAndUsage>
<Description>Folixapure is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency. Folixapure should be administered under the supervision of a licensed medical practitioner. Each tablet contains: Folic Acid ..........................................................................1700 mcg DFE. (1000 mcg folic acid) Vitamin D 3 (cholecalciferol) ......................................125 mcg. 5000 IU. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, stearic acid, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>59088-164-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-164-54) </PackageDescription>
<NDC11Code>59088-0164-54</NDC11Code>
<ProductNDC>59088-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrexyl</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200829</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>30; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 1000; 8; 200; 1500; 3; 25; 2.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitrexyl is indicated to provide vitamin supplement to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)……………. 30 mg (30IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-166-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-166-54) </PackageDescription>
<NDC11Code>59088-0166-54</NDC11Code>
<ProductNDC>59088-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatrix</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200829</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; CHROMIUM NICOTINATE; SELENIUM; POTASSIUM IODIDE; MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>27; 25; 50; 55; 45; 70; 150; 200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prenatrix is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatrix may be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Active ingredients: Each caplet contains:. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as Choline Bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: BHT, dicalcium phosphate, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-167-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-167-54) </PackageDescription>
<NDC11Code>59088-0167-54</NDC11Code>
<ProductNDC>59088-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrexate</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201130</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>30; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 1000; 8; 200; 1500; 3; 25; 2.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-168-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-168-54) </PackageDescription>
<NDC11Code>59088-0168-54</NDC11Code>
<ProductNDC>59088-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrexate Fe</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201130</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM</SubstanceName>
<StrengthNumber>35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitrexate FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age.Also for the treatment of a condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-169-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-169-54) </PackageDescription>
<NDC11Code>59088-0169-54</NDC11Code>
<ProductNDC>59088-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatryl</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201130</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. May be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Full Prescribing Information. Active ingredient: Each caplet contains:. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as choline bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-170-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-170-54) </PackageDescription>
<NDC11Code>59088-0170-54</NDC11Code>
<ProductNDC>59088-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Davimet With Fluoride</ProprietaryName>
<NonProprietaryName>Multivitamin, Fluoride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN</SubstanceName>
<StrengthNumber>.75; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 1000; 4.5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Davimet with Flouride 0.75 mg Chewable Multivitamin provide 0.75 mg fluoride in tablet form for children 6-16 years of age in areas where the drinking water fluoride level is less than 0.3 ppm. Davimet with Flouride 0.75 mg Chewable Multivitamin supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. Children using Davimet with Flouride 0.75 mg Chewable Multivitamin regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Davimet with Flouride 0.75 mg Chewable Multivitamin is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.</IndicationAndUsage>
<Description>Each Chewable Tablet Contains: Vitamin A (as Retinyl Acetate)............................................. 750 mcg RAE Vitamin C (as Sodium Ascorbate 36 mg and Ascorbic Acid 24 mg)............... 60 mg Vitamin D3 (as Cholecalciferol)......................................... 10 mcg (400IU) Vitamin E (as DL-Alpha Tocopheryl Acetate)............................... 6.75 mg Thiamin (as Thiamine Mononitrate)............................................. 1.05 mg Riboflavin...................................................................................... 1.2 mg Niacin (as Niacinamide)............................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride)................................... 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)........…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin).............................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................... 0.75 mg. Davimet with Flouride 0.75 mg Chewable Multivitamin active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Davimet with Flouride 0.75 mg Chewable Multivitamin provide sodium fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Natural Grape Flavor, Magnesium Stearate (Vegetable Source), Maltodextrin, Microcrystalline Cellulose, Stearic Acid (Vegetable Source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>59088-171-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-171-54) </PackageDescription>
<NDC11Code>59088-0171-54</NDC11Code>
<ProductNDC>59088-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitranol</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE; SELENIUM; FOLIC ACID; MAGNESIUM OXIDE; MOLYBDENUM; THIAMINE MONONITRATE; CYANOCOBALAMIN; VITAMIN A ACETATE; CHROMIUM NICOTINATE; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; ZINC OXIDE; CALCIUM CARBONATE; ASCORBIC ACID; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>20; 55; 1000; 200; 45; 3; 8; 1500; 35; 20; 3.4; 20; 30; 25; 200; 120; 2.3</StrengthNumber>
<StrengthUnit>mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-172-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-172-54) </PackageDescription>
<NDC11Code>59088-0172-54</NDC11Code>
<ProductNDC>59088-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prometa</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. May be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Full Prescribing Information. Active ingredient: Each caplet contains:. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as choline bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-173-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-173-54) </PackageDescription>
<NDC11Code>59088-0173-54</NDC11Code>
<ProductNDC>59088-173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitranol Fe</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM</SubstanceName>
<StrengthNumber>35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitranol FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)…………………………. 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-176-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-176-54) </PackageDescription>
<NDC11Code>59088-0176-54</NDC11Code>
<ProductNDC>59088-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venexa</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>30; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 1000; 8; 200; 1500; 3; 25; 2.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venexa is indicated to provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
</NDCList>