{
"NDC": [
{
"NDCCode": "59088-115-60",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (59088-115-60) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "59088-0115-60",
"ProductNDC": "59088-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Ob Dha",
"NonProprietaryName": "Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Docosahexaenoic Acid (dha)",
"DosageFormName": "KIT",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-013-06",
"PackageDescription": "60 g in 1 JAR (59088-013-06) ",
"NDC11Code": "59088-0013-06",
"ProductNDC": "59088-013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Methylten",
"NonProprietaryName": "Methyl Salicylate 10%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250113",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Puretek Corporation",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250113",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints."
},
{
"NDCCode": "59088-014-06",
"PackageDescription": "60 g in 1 JAR (59088-014-06) ",
"NDC11Code": "59088-0014-06",
"ProductNDC": "59088-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Methyl Salicylate 25%",
"ProprietaryNameSuffix": "Pain Relieving",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Puretek Corporation",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains."
},
{
"NDCCode": "59088-062-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-062-00) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60) * 1 BOTTLE, PUMP in 1 KIT > 237 mL in 1 BOTTLE, PUMP (59088-310-16) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06)",
"NDC11Code": "59088-0062-00",
"ProductNDC": "59088-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Inflammatral Pak",
"NonProprietaryName": "Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream",
"DosageFormName": "KIT",
"StartMarketingDate": "20150612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-03-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-093-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-093-00) * 237 mL in 1 BOTTLE, PUMP (59088-310-16) * 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60) ",
"NDC11Code": "59088-0093-00",
"ProductNDC": "59088-093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inflammacin",
"NonProprietaryName": "Diclofenac Sodium, Capsaicin",
"DosageFormName": "KIT",
"StartMarketingDate": "20160111",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160111",
"SamplePackage": "N",
"Description": "Diclofenac, as the sodium salt, is a benzene-acetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula:. Each enteric-coated tablet for oral administration contains 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients; black iron oxide, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, sodium starch glycolate, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "59088-180-58",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59088-180-58) ",
"NDC11Code": "59088-0180-58",
"ProductNDC": "59088-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zintrexyl-c",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210211",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 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], 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], Potassium Compounds [CS], Potassium Salt [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": "20210211",
"SamplePackage": "N",
"IndicationAndUsage": "Zintrexyl-C TM 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 the 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": "Full Prescribing Information. Each Serving Size of 2 caplets contain. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake)."
},
{
"NDCCode": "59088-181-58",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59088-181-58) ",
"NDC11Code": "59088-0181-58",
"ProductNDC": "59088-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folitin-z",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210211",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 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], 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 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": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210211",
"SamplePackage": "N",
"IndicationAndUsage": "Folitin-Z TM 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 the condition in which iron deficiency and vitamin C deficiency occurs 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. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate)................................................... 3000 mcg RAE Vitamin C (as Ascorbic Acid)............................................................... 500 mg Vitamin D (as Cholecalciferol).......................................... 3 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate)........................................... 90 mg Thiamin (as Thiamine Mononitrate)....................................................... 6.5 mg Riboflavin ............................................................................................. 6.7 mg Niacin (as Niacinamide)......................................................................... 45 mg Vitamin B6 (as Pyridoxine HCl)............................................................... 12 mg. Folate 1700 mcg DFE. (as L-5-Methyltetrahydrofolate calcium salt).........(1000 mcg as L-Methyfolate). Vitamin B12 (as Methylcobalamin)....................................................... 26 mcg Biotin ................................................................................................ 200 mcg Pantothenic Acid (as Calcium Pantothenate)........................................... 30 mg Calcium (as Calcium Carbonate)...........................................................150 mg Iron (as Ferrous Fumarate)......................................................................18 mg Iodine (as Potassium Iodide)................................................................50 mcg Magnesium (as Magnesium Oxide)........................................................ 75 mg Zinc (as Zinc Gluconate)......................................................................... 30 mg Selenium (as Selenomethionine)...........................................................60 mcg Copper (as Copper Oxide)....................................................................... 2 mg Manganese (as Manganese Sulfate).......................................................1.5 mg Chromium (as Chromium Polynicotinate)..............................................75 mcg Molybdenum (as Sodium Molybdate)................................................... 50 mcg Potassium (as Potassium Chloride)....................................................... 49 mg Boron (as Boron Citrate)...................................................................... 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake)."
},
{
"NDCCode": "59088-182-58",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59088-182-58) ",
"NDC11Code": "59088-0182-58",
"ProductNDC": "59088-182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribotin-e",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210211",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 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], 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], Potassium Compounds [CS], Potassium Salt [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": "20210211",
"SamplePackage": "N",
"IndicationAndUsage": "Ribotin-E TM 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 the 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": "Full Prescribing Information. Each Serving Size of 2 caplets contain. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake)."
},
{
"NDCCode": "59088-243-06",
"PackageDescription": "60 g in 1 JAR (59088-243-06) ",
"NDC11Code": "59088-0243-06",
"ProductNDC": "59088-243",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Methyl Salicylate 10%",
"ProprietaryNameSuffix": "Pain Relieving",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201014",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints."
},
{
"NDCCode": "59088-245-06",
"PackageDescription": "60 g in 1 JAR (59088-245-06) ",
"NDC11Code": "59088-0245-06",
"ProductNDC": "59088-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Methylten 25%",
"ProprietaryNameSuffix": "Pain Relieving",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains."
},
{
"NDCCode": "59088-480-58",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59088-480-58) ",
"NDC11Code": "59088-0480-58",
"ProductNDC": "59088-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foliflex",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211025",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 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], 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 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": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211025",
"SamplePackage": "N",
"IndicationAndUsage": "Foliflex TM 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 the 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": "Full Prescribing Information. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate) 3000 mcg RAE Vitamin C (as Ascorbic Acid) 500 mg Vitamin D3 (as Cholecalciferol) 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) 90 mg Thiamin (as Thiamine Mononitrate) 6.5 mg Riboflavin 6.7 mg Niacin (as Niacinamide) 45 mg Vitamin B6 (as Pyridoxine HCl) 12 mg Folate 1700 mcg DFE (as L-5-Methyltetrahydrofolate calcium salt) (1000 mcg as L-Methyfolate) Vitamin B12 (as Methylcobalamin) 26 mcg Biotin 200 mcg Pantothenic Acid (as Calcium Pantothenate) 30 mg Calcium (as Calcium Carbonate) 150 mg Iron (as Ferrous Fumarate) 18 mg Iodine (as Potassium Iodide) 50 mcg Magnesium (as Magnesium Oxide) 75 mg Zinc (as Zinc Gluconate) 30 mg Selenium (as Selenomethionine) 60 mcg Copper (as Copper Oxide) 2 mg Manganese (as Manganese Sulfate) 1.5 mg Chromium (as Chromium Polynicotinate) 75 mcg Molybdenum (as Sodium Molybdate) 50 mcg Potassium (as Potassium Chloride) 49 mg Boron (as Boron Citrate) 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake)."
},
{
"NDCCode": "59088-731-00",
"PackageDescription": "1 KIT in 1 KIT (59088-731-00) * 30 POUCH in 1 PACKAGE (59088-905-54) / 1 PATCH in 1 POUCH (59088-905-84) * 200 PACKET in 1 BOX (53329-805-60) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR",
"NDC11Code": "59088-0731-00",
"ProductNDC": "59088-731",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xyliderm",
"NonProprietaryName": "Lidocaine, Isopropyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20230705",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230705",
"SamplePackage": "N",
"Description": "Lidocan is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-737-05",
"PackageDescription": "1 TUBE in 1 CARTON (59088-737-05) > 60 mL in 1 TUBE",
"NDC11Code": "59088-0737-05",
"ProductNDC": "59088-737",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermalogica Oil Control",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031117",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "PureTek Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "uL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-05-04",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-744-00",
"PackageDescription": "1 KIT in 1 KIT (59088-744-00) * 1 TUBE in 1 CARTON (52565-051-60) > 60 g in 1 TUBE * 118 mL in 1 TUBE (59088-333-08) ",
"NDC11Code": "59088-0744-00",
"ProductNDC": "59088-744",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetair",
"NonProprietaryName": "Clobetair",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209974",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200323",
"SamplePackage": "N"
},
{
"NDCCode": "59088-751-00",
"PackageDescription": "1 KIT in 1 KIT (59088-751-00) * 1 TUBE in 1 CARTON (52565-051-60) > 60 g in 1 TUBE",
"NDC11Code": "59088-0751-00",
"ProductNDC": "59088-751",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tasoprol",
"NonProprietaryName": "Tasoprol",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200325",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2023-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200325",
"SamplePackage": "N"
},
{
"NDCCode": "59088-762-00",
"PackageDescription": "1 KIT in 1 KIT (59088-762-00) * 1 TUBE in 1 CARTON (52565-051-60) > 60 g in 1 TUBE * 100 TABLET, FILM COATED in 1 BOTTLE (68180-153-01) ",
"NDC11Code": "59088-0762-00",
"ProductNDC": "59088-762",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200611",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200611",
"SamplePackage": "N"
},
{
"NDCCode": "69621-093-00",
"PackageDescription": "1 KIT in 1 KIT (69621-093-00) * 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60) * 237 mL in 1 BOTTLE, PUMP (59088-310-16)",
"NDC11Code": "69621-0093-00",
"ProductNDC": "69621-093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xenaflamm",
"NonProprietaryName": "Diclofenac Sodium, Capsaicin",
"DosageFormName": "KIT",
"StartMarketingDate": "20160517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075185",
"LabelerName": "Shoreline Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-05-16",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10695-115-60",
"PackageDescription": "15 kg in 1 CONTAINER (10695-115-60) ",
"NDC11Code": "10695-0115-60",
"ProductNDC": "10695-115",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Naltrexone Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250707",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Willow Birch Pharma, LLC",
"SubstanceName": "NALTREXONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-19",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "07-JUL-25"
},
{
"NDCCode": "11788-115-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (11788-115-60) ",
"NDC11Code": "11788-0115-60",
"ProductNDC": "11788-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208856",
"LabelerName": "AiPing Pharmaceutical, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl- substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shells contain gelatin and titanium dioxide. The capsules are imprinted with edible ink containing propylene glycol and shellac. In addition, 50 mg capsules are imprinted with N-butyl alcohol, FD&C yellow No.6, D&C red No.7 and titanium dioxide. 100 mg capsules are imprinted with N-butyl alcohol, strong ammonia solution, titanium dioxide and FD&C blue No.1 aluminum lake. 200 mg capsules are imprinted with iron oxide yellow, N-butyl alcohol, ammonium hydroxide and simethicone. 400 mg capsules are imprinted with N-butyl alcohol, strong ammonia solution, titanium dioxide, FD&C blue No.1 aluminum lake and FD&C yellow No.10 aluminum lake."
},
{
"NDCCode": "16590-115-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-115-60)",
"NDC11Code": "16590-0115-60",
"ProductNDC": "16590-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19910830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081080",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone Bitartrate and Acetaminophen Tablets USP for oral administration are available in a variety of strengths as described in the following table. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid; except the 7.5 mg/325 mg, 10 mg/325 mg and 10 mg/500 mg tablets do not contain anhydrous lactose. The 7.5 mg/325 mg tablets include FD&C Yellow #6 Aluminum Lake; the 7.5 mg/650 mg tablets include FD&C Red #40 Aluminum Lake; the 10 mg/325 mg and 10 mg/750 mg tablets include D&C Yellow #10 Aluminum Lake; the 10 mg/500 mg tablets include FD&C Blue #2 Aluminum Lake; and the 10 mg/650 mg tablets include FD&C Blue #1 Aluminum Lake and D&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1."
},
{
"NDCCode": "21695-115-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (21695-115-60)",
"NDC11Code": "21695-0115-60",
"ProductNDC": "21695-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperdal",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19931229",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020272",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "RISPERDAL® is an atypical antipsychotic agent indicated for: 1 Treatment of schizophrenia in adults and adolescents aged 13–17 years (1.1), 2 Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10–17 years (1.2), 3 Treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years (1.3).",
"Description": "RISPERDAL® contains risperidone, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. RISPERDAL® Tablets are available in 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. RISPERDAL® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). The 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg tablets also contain talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake. RISPERDAL® is also available as a 1 mg/mL oral solution. RISPERDAL® Oral Solution contains the following inactive ingredients: tartaric acid, benzoic acid, sodium hydroxide, and purified water. RISPERDAL® M-TAB® Orally Disintegrating Tablets are available in 0.5 mg (light coral), 1 mg (light coral), 2 mg (coral), 3 mg (coral), and 4 mg (coral) strengths. RISPERDAL® M-TAB® Orally Disintegrating Tablets contain the following inactive ingredients: Amberlite® resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, red ferric oxide, and peppermint oil. In addition, the 2 mg, 3 mg, and 4 mg RISPERDAL® M-TAB® Orally Disintegrating Tablets contain xanthan gum."
},
{
"NDCCode": "25021-115-51",
"PackageDescription": "1 BOTTLE in 1 CARTON (25021-115-51) / 60 mL in 1 BOTTLE",
"NDC11Code": "25021-0115-51",
"ProductNDC": "25021-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090109",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120515",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection, USP is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:. Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Injection, USP and other antibacterial drugs, Clindamycin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin Injection, USP, a clear colorless to pale yellow sterile solution, contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L-threo-α-D-galacto-Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio-,2-(dihydrogen phosphate), (2S-trans)-. The molecular formula is C18H34ClN2O8PS and the molecular weight is 504.96. The structural formula is represented below:. A pharmacy bulk package is a container of a sterile preparation for intravenous use that contains many single doses. The contents are intended for use in a pharmacy admixture program utilizing a sterile transfer device and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "29300-115-16",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-16) ",
"NDC11Code": "29300-0115-16",
"ProductNDC": "29300-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090162",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130701",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
"NDCCode": "40076-115-60",
"PackageDescription": "1 TUBE in 1 CARTON (40076-115-60) > 60 g in 1 TUBE",
"NDC11Code": "40076-0115-60",
"ProductNDC": "40076-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elimite",
"NonProprietaryName": "Permethrin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076369",
"LabelerName": "Prestium Pharma, Inc.",
"SubstanceName": "PERMETHRIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/100g",
"Pharm_Classes": "Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "42254-115-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42254-115-60)",
"NDC11Code": "42254-0115-60",
"ProductNDC": "42254-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077653",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride is a white crystalline powder. It is freely soluble in water and dilute hydrochloric acid, soluble in ethanol and chloroform and insoluble in ether. Each venlafaxine hydrochloride tablet intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide yellow, ferric oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "42658-115-03",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03) ",
"NDC11Code": "42658-0115-03",
"ProductNDC": "42658-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ticagrelor",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208575",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "N",
"Description": "Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, hypromellose E5, polyethylene glycol 4000, colloidal silicon dioxide, magnesium stearate, hypromellose 2910, titanium dioxide, polyethylene glycol 400, ferric oxide yellow, ferric oxide red, and ferrosoferric oxide."
},
{
"NDCCode": "43353-115-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43353-115-60)",
"NDC11Code": "43353-0115-60",
"ProductNDC": "43353-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The drug substance used in atorvastatin calcium tablets is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, croscarmellose sodium, sodium carbonate, microcrystalline cellulose, magnesium stearate (vegetable source), colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "45865-115-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (45865-115-60) ",
"NDC11Code": "45865-0115-60",
"ProductNDC": "45865-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadolhydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "49035-115-22",
"PackageDescription": "1 BOTTLE in 1 CARTON (49035-115-22) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "49035-0115-22",
"ProductNDC": "49035-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20150215",
"EndMarketingDate": "20200430",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "EQUATE (Walmart Stores, Inc.)",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "49589-115-60",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (49589-115-60) > 40 g in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "49589-0115-60",
"ProductNDC": "49589-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Vaginal Care",
"NonProprietaryName": "Sambucus Nigra Flower, Echinacea Purpurea, And Centella Asiatica",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20150529",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Izun Pharmaceuticals Corporation",
"SubstanceName": "SAMBUCUS NIGRA FLOWER; ECHINACEA PURPUREA; CENTELLA ASIATICA",
"StrengthNumber": "2; 3; 3",
"StrengthUnit": "[hp_X]/2.5g; [hp_X]/2.5g; [hp_X]/2.5g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "relieves vaginal pain, itching, burning and discomfort."
}
]
}
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<PackageDescription>6 BLISTER PACK in 1 CARTON (59088-115-60) > 1 KIT in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>59088-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Ob Dha</ProprietaryName>
<NonProprietaryName>Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Docosahexaenoic Acid (dha)</NonProprietaryName>
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<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>59088-013-06</NDCCode>
<PackageDescription>60 g in 1 JAR (59088-013-06) </PackageDescription>
<NDC11Code>59088-0013-06</NDC11Code>
<ProductNDC>59088-013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Methylten</ProprietaryName>
<NonProprietaryName>Methyl Salicylate 10%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-014-06</NDCCode>
<PackageDescription>60 g in 1 JAR (59088-014-06) </PackageDescription>
<NDC11Code>59088-0014-06</NDC11Code>
<ProductNDC>59088-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Methyl Salicylate 25%</ProprietaryName>
<ProprietaryNameSuffix>Pain Relieving</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250612</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-062-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-062-00) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60) * 1 BOTTLE, PUMP in 1 KIT > 237 mL in 1 BOTTLE, PUMP (59088-310-16) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06)</PackageDescription>
<NDC11Code>59088-0062-00</NDC11Code>
<ProductNDC>59088-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Inflammatral Pak</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-03-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-093-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-093-00) * 237 mL in 1 BOTTLE, PUMP (59088-310-16) * 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60) </PackageDescription>
<NDC11Code>59088-0093-00</NDC11Code>
<ProductNDC>59088-093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inflammacin</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium, Capsaicin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Diclofenac, as the sodium salt, is a benzene-acetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula:. Each enteric-coated tablet for oral administration contains 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients; black iron oxide, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>59088-180-58</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59088-180-58) </PackageDescription>
<NDC11Code>59088-0180-58</NDC11Code>
<ProductNDC>59088-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zintrexyl-c</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210211</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; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 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], 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], Potassium Compounds [CS], Potassium Salt [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>20210211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zintrexyl-C TM 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 the 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>Full Prescribing Information. Each Serving Size of 2 caplets contain. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).</Description>
</NDC>
<NDC>
<NDCCode>59088-181-58</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59088-181-58) </PackageDescription>
<NDC11Code>59088-0181-58</NDC11Code>
<ProductNDC>59088-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folitin-z</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210211</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; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 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], 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 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>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folitin-Z TM 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 the condition in which iron deficiency and vitamin C deficiency occurs 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. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate)................................................... 3000 mcg RAE Vitamin C (as Ascorbic Acid)............................................................... 500 mg Vitamin D (as Cholecalciferol).......................................... 3 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate)........................................... 90 mg Thiamin (as Thiamine Mononitrate)....................................................... 6.5 mg Riboflavin ............................................................................................. 6.7 mg Niacin (as Niacinamide)......................................................................... 45 mg Vitamin B6 (as Pyridoxine HCl)............................................................... 12 mg. Folate 1700 mcg DFE. (as L-5-Methyltetrahydrofolate calcium salt).........(1000 mcg as L-Methyfolate). Vitamin B12 (as Methylcobalamin)....................................................... 26 mcg Biotin ................................................................................................ 200 mcg Pantothenic Acid (as Calcium Pantothenate)........................................... 30 mg Calcium (as Calcium Carbonate)...........................................................150 mg Iron (as Ferrous Fumarate)......................................................................18 mg Iodine (as Potassium Iodide)................................................................50 mcg Magnesium (as Magnesium Oxide)........................................................ 75 mg Zinc (as Zinc Gluconate)......................................................................... 30 mg Selenium (as Selenomethionine)...........................................................60 mcg Copper (as Copper Oxide)....................................................................... 2 mg Manganese (as Manganese Sulfate).......................................................1.5 mg Chromium (as Chromium Polynicotinate)..............................................75 mcg Molybdenum (as Sodium Molybdate)................................................... 50 mcg Potassium (as Potassium Chloride)....................................................... 49 mg Boron (as Boron Citrate)...................................................................... 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).</Description>
</NDC>
<NDC>
<NDCCode>59088-182-58</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59088-182-58) </PackageDescription>
<NDC11Code>59088-0182-58</NDC11Code>
<ProductNDC>59088-182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ribotin-e</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210211</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; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 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], 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], Potassium Compounds [CS], Potassium Salt [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>20210211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ribotin-E TM 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 the 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>Full Prescribing Information. Each Serving Size of 2 caplets contain. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).</Description>
</NDC>
<NDC>
<NDCCode>59088-243-06</NDCCode>
<PackageDescription>60 g in 1 JAR (59088-243-06) </PackageDescription>
<NDC11Code>59088-0243-06</NDC11Code>
<ProductNDC>59088-243</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Methyl Salicylate 10%</ProprietaryName>
<ProprietaryNameSuffix>Pain Relieving</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201014</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-245-06</NDCCode>
<PackageDescription>60 g in 1 JAR (59088-245-06) </PackageDescription>
<NDC11Code>59088-0245-06</NDC11Code>
<ProductNDC>59088-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Methylten 25%</ProprietaryName>
<ProprietaryNameSuffix>Pain Relieving</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250612</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-480-58</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59088-480-58) </PackageDescription>
<NDC11Code>59088-0480-58</NDC11Code>
<ProductNDC>59088-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foliflex</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211025</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; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 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], 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 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>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Foliflex TM 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 the 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>Full Prescribing Information. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate) 3000 mcg RAE Vitamin C (as Ascorbic Acid) 500 mg Vitamin D3 (as Cholecalciferol) 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) 90 mg Thiamin (as Thiamine Mononitrate) 6.5 mg Riboflavin 6.7 mg Niacin (as Niacinamide) 45 mg Vitamin B6 (as Pyridoxine HCl) 12 mg Folate 1700 mcg DFE (as L-5-Methyltetrahydrofolate calcium salt) (1000 mcg as L-Methyfolate) Vitamin B12 (as Methylcobalamin) 26 mcg Biotin 200 mcg Pantothenic Acid (as Calcium Pantothenate) 30 mg Calcium (as Calcium Carbonate) 150 mg Iron (as Ferrous Fumarate) 18 mg Iodine (as Potassium Iodide) 50 mcg Magnesium (as Magnesium Oxide) 75 mg Zinc (as Zinc Gluconate) 30 mg Selenium (as Selenomethionine) 60 mcg Copper (as Copper Oxide) 2 mg Manganese (as Manganese Sulfate) 1.5 mg Chromium (as Chromium Polynicotinate) 75 mcg Molybdenum (as Sodium Molybdate) 50 mcg Potassium (as Potassium Chloride) 49 mg Boron (as Boron Citrate) 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).</Description>
</NDC>
<NDC>
<NDCCode>59088-731-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-731-00) * 30 POUCH in 1 PACKAGE (59088-905-54) / 1 PATCH in 1 POUCH (59088-905-84) * 200 PACKET in 1 BOX (53329-805-60) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>59088-0731-00</NDC11Code>
<ProductNDC>59088-731</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xyliderm</ProprietaryName>
<NonProprietaryName>Lidocaine, Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230705</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lidocan is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-737-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59088-737-05) > 60 mL in 1 TUBE</PackageDescription>
<NDC11Code>59088-0737-05</NDC11Code>
<ProductNDC>59088-737</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermalogica Oil Control</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>uL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-05-04</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-744-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-744-00) * 1 TUBE in 1 CARTON (52565-051-60) > 60 g in 1 TUBE * 118 mL in 1 TUBE (59088-333-08) </PackageDescription>
<NDC11Code>59088-0744-00</NDC11Code>
<ProductNDC>59088-744</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetair</ProprietaryName>
<NonProprietaryName>Clobetair</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209974</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-751-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-751-00) * 1 TUBE in 1 CARTON (52565-051-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0751-00</NDC11Code>
<ProductNDC>59088-751</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tasoprol</ProprietaryName>
<NonProprietaryName>Tasoprol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200325</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-762-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-762-00) * 1 TUBE in 1 CARTON (52565-051-60) > 60 g in 1 TUBE * 100 TABLET, FILM COATED in 1 BOTTLE (68180-153-01) </PackageDescription>
<NDC11Code>59088-0762-00</NDC11Code>
<ProductNDC>59088-762</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetex</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200611</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69621-093-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (69621-093-00) * 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60) * 237 mL in 1 BOTTLE, PUMP (59088-310-16)</PackageDescription>
<NDC11Code>69621-0093-00</NDC11Code>
<ProductNDC>69621-093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xenaflamm</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium, Capsaicin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075185</ApplicationNumber>
<LabelerName>Shoreline Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-05-16</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10695-115-60</NDCCode>
<PackageDescription>15 kg in 1 CONTAINER (10695-115-60) </PackageDescription>
<NDC11Code>10695-0115-60</NDC11Code>
<ProductNDC>10695-115</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Naltrexone Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250707</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Willow Birch Pharma, LLC</LabelerName>
<SubstanceName>NALTREXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-19</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>07-JUL-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11788-115-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (11788-115-60) </PackageDescription>
<NDC11Code>11788-0115-60</NDC11Code>
<ProductNDC>11788-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208856</ApplicationNumber>
<LabelerName>AiPing Pharmaceutical, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl- substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shells contain gelatin and titanium dioxide. The capsules are imprinted with edible ink containing propylene glycol and shellac. In addition, 50 mg capsules are imprinted with N-butyl alcohol, FD&C yellow No.6, D&C red No.7 and titanium dioxide. 100 mg capsules are imprinted with N-butyl alcohol, strong ammonia solution, titanium dioxide and FD&C blue No.1 aluminum lake. 200 mg capsules are imprinted with iron oxide yellow, N-butyl alcohol, ammonium hydroxide and simethicone. 400 mg capsules are imprinted with N-butyl alcohol, strong ammonia solution, titanium dioxide, FD&C blue No.1 aluminum lake and FD&C yellow No.10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>16590-115-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16590-115-60)</PackageDescription>
<NDC11Code>16590-0115-60</NDC11Code>
<ProductNDC>16590-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081080</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone Bitartrate and Acetaminophen Tablets USP for oral administration are available in a variety of strengths as described in the following table. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid; except the 7.5 mg/325 mg, 10 mg/325 mg and 10 mg/500 mg tablets do not contain anhydrous lactose. The 7.5 mg/325 mg tablets include FD&C Yellow #6 Aluminum Lake; the 7.5 mg/650 mg tablets include FD&C Red #40 Aluminum Lake; the 10 mg/325 mg and 10 mg/750 mg tablets include D&C Yellow #10 Aluminum Lake; the 10 mg/500 mg tablets include FD&C Blue #2 Aluminum Lake; and the 10 mg/650 mg tablets include FD&C Blue #1 Aluminum Lake and D&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>21695-115-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (21695-115-60)</PackageDescription>
<NDC11Code>21695-0115-60</NDC11Code>
<ProductNDC>21695-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperdal</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931229</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020272</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>RISPERDAL® is an atypical antipsychotic agent indicated for: 1 Treatment of schizophrenia in adults and adolescents aged 13–17 years (1.1), 2 Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10–17 years (1.2), 3 Treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years (1.3).</IndicationAndUsage>
<Description>RISPERDAL® contains risperidone, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. RISPERDAL® Tablets are available in 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. RISPERDAL® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). The 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg tablets also contain talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake. RISPERDAL® is also available as a 1 mg/mL oral solution. RISPERDAL® Oral Solution contains the following inactive ingredients: tartaric acid, benzoic acid, sodium hydroxide, and purified water. RISPERDAL® M-TAB® Orally Disintegrating Tablets are available in 0.5 mg (light coral), 1 mg (light coral), 2 mg (coral), 3 mg (coral), and 4 mg (coral) strengths. RISPERDAL® M-TAB® Orally Disintegrating Tablets contain the following inactive ingredients: Amberlite® resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, red ferric oxide, and peppermint oil. In addition, the 2 mg, 3 mg, and 4 mg RISPERDAL® M-TAB® Orally Disintegrating Tablets contain xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>25021-115-51</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (25021-115-51) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>25021-0115-51</NDC11Code>
<ProductNDC>25021-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090109</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection, USP is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:. Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Injection, USP and other antibacterial drugs, Clindamycin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin Injection, USP, a clear colorless to pale yellow sterile solution, contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L-threo-α-D-galacto-Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio-,2-(dihydrogen phosphate), (2S-trans)-. The molecular formula is C18H34ClN2O8PS and the molecular weight is 504.96. The structural formula is represented below:. A pharmacy bulk package is a container of a sterile preparation for intravenous use that contains many single doses. The contents are intended for use in a pharmacy admixture program utilizing a sterile transfer device and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>29300-115-16</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-16) </PackageDescription>
<NDC11Code>29300-0115-16</NDC11Code>
<ProductNDC>29300-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090162</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>40076-115-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (40076-115-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>40076-0115-60</NDC11Code>
<ProductNDC>40076-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elimite</ProprietaryName>
<NonProprietaryName>Permethrin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076369</ApplicationNumber>
<LabelerName>Prestium Pharma, Inc.</LabelerName>
<SubstanceName>PERMETHRIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/100g</StrengthUnit>
<Pharm_Classes>Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>42254-115-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42254-115-60)</PackageDescription>
<NDC11Code>42254-0115-60</NDC11Code>
<ProductNDC>42254-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077653</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride is a white crystalline powder. It is freely soluble in water and dilute hydrochloric acid, soluble in ethanol and chloroform and insoluble in ether. Each venlafaxine hydrochloride tablet intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide yellow, ferric oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42658-115-03</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03) </PackageDescription>
<NDC11Code>42658-0115-03</NDC11Code>
<ProductNDC>42658-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ticagrelor</ProprietaryName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208575</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, hypromellose E5, polyethylene glycol 4000, colloidal silicon dioxide, magnesium stearate, hypromellose 2910, titanium dioxide, polyethylene glycol 400, ferric oxide yellow, ferric oxide red, and ferrosoferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-115-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43353-115-60)</PackageDescription>
<NDC11Code>43353-0115-60</NDC11Code>
<ProductNDC>43353-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The drug substance used in atorvastatin calcium tablets is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, croscarmellose sodium, sodium carbonate, microcrystalline cellulose, magnesium stearate (vegetable source), colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>45865-115-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45865-115-60) </PackageDescription>
<NDC11Code>45865-0115-60</NDC11Code>
<ProductNDC>45865-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadolhydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>49035-115-22</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49035-115-22) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>49035-0115-22</NDC11Code>
<ProductNDC>49035-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150215</StartMarketingDate>
<EndMarketingDate>20200430</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>EQUATE (Walmart Stores, Inc.)</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>49589-115-60</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (49589-115-60) > 40 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>49589-0115-60</NDC11Code>
<ProductNDC>49589-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural Vaginal Care</ProprietaryName>
<NonProprietaryName>Sambucus Nigra Flower, Echinacea Purpurea, And Centella Asiatica</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20150529</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Izun Pharmaceuticals Corporation</LabelerName>
<SubstanceName>SAMBUCUS NIGRA FLOWER; ECHINACEA PURPUREA; CENTELLA ASIATICA</SubstanceName>
<StrengthNumber>2; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/2.5g; [hp_X]/2.5g; [hp_X]/2.5g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>relieves vaginal pain, itching, burning and discomfort.</IndicationAndUsage>
</NDC>
</NDCList>