{
"NDC": [
{
"NDCCode": "59088-332-31",
"PackageDescription": "500 mL in 1 BOTTLE, PUMP (59088-332-31) ",
"NDC11Code": "59088-0332-31",
"ProductNDC": "59088-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200424",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200424",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "59088-332-08",
"PackageDescription": "118 mL in 1 BOTTLE, DISPENSING (59088-332-08) ",
"NDC11Code": "59088-0332-08",
"ProductNDC": "59088-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200424",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200424",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "59088-332-39",
"PackageDescription": "709 mL in 1 BOTTLE, PUMP (59088-332-39) ",
"NDC11Code": "59088-0332-39",
"ProductNDC": "59088-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200424",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200424",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "46708-332-31",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-31) ",
"NDC11Code": "46708-0332-31",
"ProductNDC": "46708-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210341",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2019-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190606",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release tablets, USP are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP , an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white, odorless or practically odorless powder, freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as (-)-L-αhydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.24. Levodopa, USP, an aromatic amino acid, is a white to off-white, odorless , crystalline powder, slightly soluble in water, freely soluble in 3N hydrochloric acid and insoluble in alcohol with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, magnesium stearate, and hypromellose. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&C Blue #2 Aluminium Lake and FD&C Red #40 Aluminium Lake. The 25 mg/100 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L519” on one side and plain on the other. The 50 mg/200 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L520” on one side and plain on the other. Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablet 25 mg/100 mg is available to facilitate titration when 100 mg steps are required. FDA approved dissolution specifications differs from the USP dissolution specifications."
},
{
"NDCCode": "62332-332-31",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-332-31) ",
"NDC11Code": "62332-0332-31",
"ProductNDC": "62332-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210341",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190606",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release tablets, USP are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white, odorless or practically odorless powder, freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as (-)-L-αhydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.24.Levodopa, USP, an aromatic amino acid, is a white to off-white, odorless, crystalline powder, slightly soluble in water, freely soluble in 3N hydrochloric acid and insoluble in alcohol with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, hypromellose and magnesium stearate. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&C Blue #2 Aluminium Lake and FD&C Red #40 Aluminium Lake. The 25 mg/100 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L519” on one side and plain on the other. The 50 mg/200 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L520” on one side and plain on the other. Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablet 25 mg/100 mg is available to facilitate titration when 100 mg steps are required. FDA approved dissolution specifications differs from the USP dissolution specifications."
},
{
"NDCCode": "59088-201-31",
"PackageDescription": "480 mL in 1 BOTTLE (59088-201-31) ",
"NDC11Code": "59088-0201-31",
"ProductNDC": "59088-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Liquical Plus",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240612",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLECALCIFEROL; ZINC CITRATE; MAGNESIUM CITRATE; CALCIUM CITRATE",
"StrengthNumber": "1200; 2.1; 72; 252",
"StrengthUnit": "[iU]/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240612",
"SamplePackage": "N",
"IndicationAndUsage": "LiquiCal Plus is indicated for dietary management of patients with unique nutritional needs requiring increased Vitamin D3 and essential minerals, including Calcium, Magnesium, and Zinc in a convenient liquid form for easy administration.",
"Description": "LiquiCal Plus Rx Only Full Prescribing Information. Active Ingredients: Each 5 mL Contains: Vitamin D3 (as Cholecalciferol) ................................................................. 10 mcg (400 IU) Calcium (as Calcium Citrate) ..................................................................................... 84 mg Magnesium (as Magnesium Citrate) ......................................................................... 24 mg Zinc (as Zinc Citrate) ................................................................................................ 0.7 mg. Each 15 mL Contains: Vitamin D3 (as Cholecalciferol) ............................................................... 30 mcg (1200 IU) Calcium (as Calcium Citrate) ................................................................................... 252 mg Magnesium (as Magnesium Citrate) ......................................................................... 72 mg Zinc (as Zinc Citrate) ................................................................................................ 2.1 mg. Other Ingredients: Agave Tequilana (Tequila Agave) Stem Extract, Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum."
},
{
"NDCCode": "59088-299-31",
"PackageDescription": "500 mL in 1 BOTTLE, DISPENSING (59088-299-31) ",
"NDC11Code": "59088-0299-31",
"ProductNDC": "59088-299",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genrx Anti-bacterial Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200318",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200318",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "59088-370-31",
"PackageDescription": "473 mL in 1 BOTTLE (59088-370-31) ",
"NDC11Code": "59088-0370-31",
"ProductNDC": "59088-370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200515",
"SamplePackage": "N"
},
{
"NDCCode": "59088-413-31",
"PackageDescription": "500 mL in 1 BOTTLE (59088-413-31) ",
"NDC11Code": "59088-0413-31",
"ProductNDC": "59088-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing With Lavender Oil",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200605",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200605",
"SamplePackage": "N",
"IndicationAndUsage": "■ Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "59088-659-31",
"PackageDescription": "480 mL in 1 BOTTLE (59088-659-31) ",
"NDC11Code": "59088-0659-31",
"ProductNDC": "59088-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Livita Adults",
"NonProprietaryName": "Folate, Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN",
"StrengthNumber": "200; 10; 900; 200; 30; 1.2; 1.3; 8; 1.7; 1000; 2.4; 30; 2; 100; 5; 200; 500",
"StrengthUnit": "mg/15mL; ug/15mL; ug/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; ug/15mL; ug/15mL; ug/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231215",
"SamplePackage": "N",
"IndicationAndUsage": "Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.",
"Description": "Active Ingredients: Amount Per Serving:. Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE Vitamin C (as Ascorbic Acid)............................................... 200 mg Vitamin D3 (as Cholecalciferol)............................................ 10 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............................ 30 mg Thiamin (as Thiamine Mononitrate)...................................... 1.2 mg Riboflavin ............................................................................. 1.3 mg Niacin (as Niacinamide)........................................................... 8 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................ 1.7 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...1700 mcg DFE (1000 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin and Hydroxocobalamin)...2.4 mcg Biotin (as D-Biotin)............................................................... 30 mcg Pantothenic Acid (as D-Calcium Pantothenate)........................ 5 mg Choline (as Choline Bitartrate)............................................. 200 mg Calcium (as Calcium Citrate)................................................ 200 mg Magnesium (as Magnesium Citrate).................................... 100 mg Zinc (as Zinc Picolinate)........................................................... 2 mg Inulin (as Helianthus Tuberosus Root Extract)..................... 500 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract."
},
{
"NDCCode": "59088-723-00",
"PackageDescription": "1 KIT in 1 KIT (59088-723-00) * 100 CAPSULE in 1 BOTTLE (62332-141-31) * 59 mL in 1 BOTTLE, SPRAY (GS1:7-31477-27221-7) ",
"NDC11Code": "59088-0723-00",
"ProductNDC": "59088-723",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celexib 100-ezs",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "KIT",
"StartMarketingDate": "20181022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204519",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181022",
"SamplePackage": "N"
},
{
"NDCCode": "59088-786-31",
"PackageDescription": "480 mL in 1 BOTTLE (59088-786-31) ",
"NDC11Code": "59088-0786-31",
"ProductNDC": "59088-786",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Liquical With Magnesium",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20231227",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CALCIUM CITRATE; CHOLECALCIFEROL; MAGNESIUM CITRATE; ZINC CITRATE",
"StrengthNumber": "168; 66; 48; 1.4",
"StrengthUnit": "mg/mL; [iU]/mL; mg/mL; mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231227",
"SamplePackage": "N",
"IndicationAndUsage": "LiquiCal with Magnesium is indicated to provide support in children's healthy bone growth and development.",
"Description": "Vitamin D3 (Cholecalciferol): Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Calcium (Calcium Citrate): Calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Citrate): Magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. Zinc Citrate: Zinc is an essential trace element that has a critical role in maintaining structural and catalytic functions of >200 enzymes involved in major metabolic pathways, including nucleic acid metabolism, protein synthesis, and cell division. OTHER INGREDIENTS: Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum, Xylitol."
},
{
"NDCCode": "59088-113-66",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (59088-113-66)",
"NDC11Code": "59088-0113-66",
"ProductNDC": "59088-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Purefe Ob Plus",
"NonProprietaryName": "Ferrous Fumarate And Polysaccharide Iron Complex",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; MAGNESIUM SULFATE, UNSPECIFIED; ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE",
"StrengthNumber": "53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 6.9; 18.2; .8; 1.3",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"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": "59088-210-16",
"PackageDescription": "227 g in 1 JAR (59088-210-16) ",
"NDC11Code": "59088-0210-16",
"ProductNDC": "59088-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea 39.5% With 2% Salicylic Acid",
"NonProprietaryName": "Urea, Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230324",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "UREA; SALICYLIC ACID",
"StrengthNumber": "39.5; 2",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2023-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230324",
"SamplePackage": "N",
"IndicationAndUsage": "For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.",
"Description": "Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space. Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of: Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid. Urea is a diamide of carbonic acid with the following chemical structure."
},
{
"NDCCode": "59088-378-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-378-00) * 5 g in 1 TUBE (0168-0357-05) * 1 in 1 BAG (GS1:19555240400625)",
"NDC11Code": "59088-0378-00",
"ProductNDC": "59088-378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venipuncture Cpi",
"NonProprietaryName": "Lidocaine And Prilocaine",
"DosageFormName": "KIT",
"StartMarketingDate": "20160509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076453",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-660-16",
"PackageDescription": "237 mL in 1 BOTTLE (59088-660-16) ",
"NDC11Code": "59088-0660-16",
"ProductNDC": "59088-660",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Livita Children",
"NonProprietaryName": "Folate, Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20231218",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN",
"StrengthNumber": "66.67; 3.33; 300; 66.67; 10; .4; .43; 2.67; .57; 333; .8; 10; .67; 33.33; 1.67; 66.67; 166.67",
"StrengthUnit": "mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231218",
"SamplePackage": "N",
"IndicationAndUsage": "Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.",
"Description": "Serving Size: 15 mL Servings per container: 47. Vitamin A (as Retinyl Acetate)........................ 300 mcg RAE Vitamin C (as Ascorbic Acid)............................... 66.67 mg Vitamin D3 (as Cholecalciferol)............................ 3.33 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............. 10 mg Thiamin (as Thiamine Mononitrate)......................... 0.4 mg Riboflavin .............................................................. 0.43 mg Niacin (as Niacinamide)......................................... 2.67 mg Vitamin B6 (as Pyridoxine Hydrochloride)............. 0.57 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...566 mcg DFE (333 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................... 0.8 mcg Biotin (as D-Biotin)................................................. 10 mcg Pantothenic Acid (as D-Calcium Pantothenate)..... 1.67 mg Choline (as Choline Bitartrate)............................. 66.67 mg Calcium (as Calcium Citrate)............................... 66.67 mg Magnesium (as Magnesium Citrate)...................... 33.3 mg Zinc (as Zinc Picolinate)........................................ 0.67 mg Inulin (as Helianthus Tuberosus Root Extract)... 166.67 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract."
},
{
"NDCCode": "59088-771-07",
"PackageDescription": "7 g in 1 TUBE (59088-771-07) ",
"NDC11Code": "59088-0771-07",
"ProductNDC": "59088-771",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "30; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula. NGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 1% CreamEach gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 1%."
},
{
"NDCCode": "59088-771-20",
"PackageDescription": "20 TUBE in 1 KIT (59088-771-20) / 7 g in 1 TUBE (59088-771-01) ",
"NDC11Code": "59088-0771-20",
"ProductNDC": "59088-771",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "30; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"EndMarketingDatePackage": "20250530",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula. NGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 1% CreamEach gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 1%."
},
{
"NDCCode": "59088-798-00",
"PackageDescription": "1 KIT in 1 KIT (59088-798-00) * 1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2) / 150 mL in 1 BOTTLE, DROPPER * 237 mL in 1 BOTTLE, PUMP (59088-310-16) ",
"NDC11Code": "59088-0798-00",
"ProductNDC": "59088-798",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lextol",
"NonProprietaryName": "Diclofenac Sodium, Capsaicin",
"DosageFormName": "KIT",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2023-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N"
},
{
"NDCCode": "59088-816-01",
"PackageDescription": "7 g in 1 TUBE (59088-816-01) ",
"NDC11Code": "59088-0816-01",
"ProductNDC": "59088-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. INGREDIENTS: PharmaPure Rx Lidocaine HCl 2% - Hydrocortisone Acetate 2% Cream. Each gram contains Lidocaine HCl 20 mg, Hydrocortisone Acetate 20 mg. ACTIVE INGREDIENTS. LIDOCAINE HCl 2% HYDROCORTISONE ACETATE 2%."
},
{
"NDCCode": "59088-817-01",
"PackageDescription": "1 TUBE in 1 KIT (59088-817-01) / 100 g in 1 TUBE (59088-817-07) ",
"NDC11Code": "59088-0817-01",
"ProductNDC": "59088-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"ProprietaryNameSuffix": "With Aloe",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "GEL",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "28; 5.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%."
},
{
"NDCCode": "59088-817-07",
"PackageDescription": "100 g in 1 TUBE (59088-817-07) ",
"NDC11Code": "59088-0817-07",
"ProductNDC": "59088-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"ProprietaryNameSuffix": "With Aloe",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "GEL",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "28; 5.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%."
},
{
"NDCCode": "59088-900-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-900-54) / 14 g in 1 POUCH (59088-900-84) ",
"NDC11Code": "59088-0900-54",
"ProductNDC": "59088-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Vii",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240808",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan VII is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan VII is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film 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": "59088-907-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-907-54) / 14 g in 1 POUCH (59088-907-84) ",
"NDC11Code": "59088-0907-54",
"ProductNDC": "59088-907",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Iii",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "LIDOCAN III is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "LIDOCAN III is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film 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": "59088-909-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-909-54) / 14 g in 1 POUCH (59088-909-84) ",
"NDC11Code": "59088-0909-54",
"ProductNDC": "59088-909",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan V",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan V is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan V is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film 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": "59088-911-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-911-54) / 14 g in 1 POUCH (59088-911-84) ",
"NDC11Code": "59088-0911-54",
"ProductNDC": "59088-911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Vi",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240621",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan VI is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan VI is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film 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": "59088-997-07",
"PackageDescription": "1 TUBE in 1 CARTON (59088-997-07) > 85 g in 1 TUBE",
"NDC11Code": "59088-0997-07",
"ProductNDC": "59088-997",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl",
"NonProprietaryName": "Lidocaine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110613",
"SamplePackage": "N",
"IndicationAndUsage": "Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.",
"Description": "Contains lidocaine HCl 3% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl). INGREDIENTS: Each gram of PharmaPure Rx Lidocaine HCl 3% Cream contains Lidocaine HCl USP 3%, Inactive ingredients include: Aluminum Sulfate, Calcium Acetate, Cetyl Alcohol, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sodium Hydroxide, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol."
},
{
"NDCCode": "0065-0092-65",
"PackageDescription": "12 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL",
"NDC11Code": "00065-0092-65",
"ProductNDC": "0065-0092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorescite",
"NonProprietaryName": "Fluorescein Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19720915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021980",
"LabelerName": "Alcon, Inc.",
"SubstanceName": "FLUORESCEIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Diagnostic Dye [EPC], Dyes [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19720915",
"SamplePackage": "N",
"IndicationAndUsage": "FLUORESCITE® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.",
"Description": "FLUORESCITE® (fluorescein injection, USP) 10% contains 10% w/v fluorescein. It is a sterile solution for use intravenously as a diagnostic aid. Its chemical name is 3’,6’-dihydroxyspiro[isobenzofuran-1(3H),9’-[9H]xanthene]-3-one. The molecular weight is 332.31 g/mol. The active ingredient is represented by the chemical structure. FLUORESCITE® (fluorescein injection, USP) 10% is supplied as a sterile, unpreserved, unit dose aqueous solution, that has a pH of 8.0 – 9.8 and an osmolality of 572-858 mOsm/kg. Active ingredient: fluorescein sodium. Inactive Ingredients: Sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection."
},
{
"NDCCode": "0703-4094-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0703-4094-01) / 5 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00703-4094-01",
"ProductNDC": "0703-4094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Palonosetron Hydrochloride",
"NonProprietaryName": "Palonosetron Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180323",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090713",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PALONOSETRON HYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180323",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Palonosetron hydrochloride injection is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.",
"Description": "Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. Palonosetron hydrochloride exists as a single isomer and has the following structural formula:. C19H24N2OHCl M.W. 332.87. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL single-dose vial. Each 5 mL vial contains 0.25 mg palonosetron base as 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, edetate disodium, trisodium citrate and citric acid in water for intravenous administration. The pH of the solution is 4.5 to 5.5."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59088-332-31</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, PUMP (59088-332-31) </PackageDescription>
<NDC11Code>59088-0332-31</NDC11Code>
<ProductNDC>59088-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200424</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200424</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-332-08</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DISPENSING (59088-332-08) </PackageDescription>
<NDC11Code>59088-0332-08</NDC11Code>
<ProductNDC>59088-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200424</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200424</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-332-39</NDCCode>
<PackageDescription>709 mL in 1 BOTTLE, PUMP (59088-332-39) </PackageDescription>
<NDC11Code>59088-0332-39</NDC11Code>
<ProductNDC>59088-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200424</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200424</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46708-332-31</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-31) </PackageDescription>
<NDC11Code>46708-0332-31</NDC11Code>
<ProductNDC>46708-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210341</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release tablets, USP are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP , an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white, odorless or practically odorless powder, freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as (-)-L-αhydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.24. Levodopa, USP, an aromatic amino acid, is a white to off-white, odorless , crystalline powder, slightly soluble in water, freely soluble in 3N hydrochloric acid and insoluble in alcohol with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, magnesium stearate, and hypromellose. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&C Blue #2 Aluminium Lake and FD&C Red #40 Aluminium Lake. The 25 mg/100 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L519” on one side and plain on the other. The 50 mg/200 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L520” on one side and plain on the other. Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablet 25 mg/100 mg is available to facilitate titration when 100 mg steps are required. FDA approved dissolution specifications differs from the USP dissolution specifications.</Description>
</NDC>
<NDC>
<NDCCode>62332-332-31</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-332-31) </PackageDescription>
<NDC11Code>62332-0332-31</NDC11Code>
<ProductNDC>62332-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210341</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release tablets, USP are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white, odorless or practically odorless powder, freely soluble in 3N hydrochloric acid, slightly soluble in water and in methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as (-)-L-αhydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.24.Levodopa, USP, an aromatic amino acid, is a white to off-white, odorless, crystalline powder, slightly soluble in water, freely soluble in 3N hydrochloric acid and insoluble in alcohol with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, hypromellose and magnesium stearate. Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg also contain FD&C Blue #2 Aluminium Lake and FD&C Red #40 Aluminium Lake. The 25 mg/100 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L519” on one side and plain on the other. The 50 mg/200 mg tablet is supplied as an oval shaped mottled tablet that is dappled-purple in color and is debossed with “L520” on one side and plain on the other. Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablet 25 mg/100 mg is available to facilitate titration when 100 mg steps are required. FDA approved dissolution specifications differs from the USP dissolution specifications.</Description>
</NDC>
<NDC>
<NDCCode>59088-201-31</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (59088-201-31) </PackageDescription>
<NDC11Code>59088-0201-31</NDC11Code>
<ProductNDC>59088-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Liquical Plus</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240612</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLECALCIFEROL; ZINC CITRATE; MAGNESIUM CITRATE; CALCIUM CITRATE</SubstanceName>
<StrengthNumber>1200; 2.1; 72; 252</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LiquiCal Plus is indicated for dietary management of patients with unique nutritional needs requiring increased Vitamin D3 and essential minerals, including Calcium, Magnesium, and Zinc in a convenient liquid form for easy administration.</IndicationAndUsage>
<Description>LiquiCal Plus Rx Only Full Prescribing Information. Active Ingredients: Each 5 mL Contains: Vitamin D3 (as Cholecalciferol) ................................................................. 10 mcg (400 IU) Calcium (as Calcium Citrate) ..................................................................................... 84 mg Magnesium (as Magnesium Citrate) ......................................................................... 24 mg Zinc (as Zinc Citrate) ................................................................................................ 0.7 mg. Each 15 mL Contains: Vitamin D3 (as Cholecalciferol) ............................................................... 30 mcg (1200 IU) Calcium (as Calcium Citrate) ................................................................................... 252 mg Magnesium (as Magnesium Citrate) ......................................................................... 72 mg Zinc (as Zinc Citrate) ................................................................................................ 2.1 mg. Other Ingredients: Agave Tequilana (Tequila Agave) Stem Extract, Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum.</Description>
</NDC>
<NDC>
<NDCCode>59088-299-31</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, DISPENSING (59088-299-31) </PackageDescription>
<NDC11Code>59088-0299-31</NDC11Code>
<ProductNDC>59088-299</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genrx Anti-bacterial Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200318</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-370-31</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (59088-370-31) </PackageDescription>
<NDC11Code>59088-0370-31</NDC11Code>
<ProductNDC>59088-370</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-413-31</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (59088-413-31) </PackageDescription>
<NDC11Code>59088-0413-31</NDC11Code>
<ProductNDC>59088-413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing With Lavender Oil</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-659-31</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (59088-659-31) </PackageDescription>
<NDC11Code>59088-0659-31</NDC11Code>
<ProductNDC>59088-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Livita Adults</ProprietaryName>
<NonProprietaryName>Folate, Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN</SubstanceName>
<StrengthNumber>200; 10; 900; 200; 30; 1.2; 1.3; 8; 1.7; 1000; 2.4; 30; 2; 100; 5; 200; 500</StrengthNumber>
<StrengthUnit>mg/15mL; ug/15mL; ug/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; ug/15mL; ug/15mL; ug/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.</IndicationAndUsage>
<Description>Active Ingredients: Amount Per Serving:. Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE Vitamin C (as Ascorbic Acid)............................................... 200 mg Vitamin D3 (as Cholecalciferol)............................................ 10 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............................ 30 mg Thiamin (as Thiamine Mononitrate)...................................... 1.2 mg Riboflavin ............................................................................. 1.3 mg Niacin (as Niacinamide)........................................................... 8 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................ 1.7 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...1700 mcg DFE (1000 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin and Hydroxocobalamin)...2.4 mcg Biotin (as D-Biotin)............................................................... 30 mcg Pantothenic Acid (as D-Calcium Pantothenate)........................ 5 mg Choline (as Choline Bitartrate)............................................. 200 mg Calcium (as Calcium Citrate)................................................ 200 mg Magnesium (as Magnesium Citrate).................................... 100 mg Zinc (as Zinc Picolinate)........................................................... 2 mg Inulin (as Helianthus Tuberosus Root Extract)..................... 500 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract.</Description>
</NDC>
<NDC>
<NDCCode>59088-723-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-723-00) * 100 CAPSULE in 1 BOTTLE (62332-141-31) * 59 mL in 1 BOTTLE, SPRAY (GS1:7-31477-27221-7) </PackageDescription>
<NDC11Code>59088-0723-00</NDC11Code>
<ProductNDC>59088-723</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celexib 100-ezs</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204519</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-786-31</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (59088-786-31) </PackageDescription>
<NDC11Code>59088-0786-31</NDC11Code>
<ProductNDC>59088-786</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Liquical With Magnesium</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231227</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CALCIUM CITRATE; CHOLECALCIFEROL; MAGNESIUM CITRATE; ZINC CITRATE</SubstanceName>
<StrengthNumber>168; 66; 48; 1.4</StrengthNumber>
<StrengthUnit>mg/mL; [iU]/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LiquiCal with Magnesium is indicated to provide support in children's healthy bone growth and development.</IndicationAndUsage>
<Description>Vitamin D3 (Cholecalciferol): Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Calcium (Calcium Citrate): Calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Citrate): Magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. Zinc Citrate: Zinc is an essential trace element that has a critical role in maintaining structural and catalytic functions of >200 enzymes involved in major metabolic pathways, including nucleic acid metabolism, protein synthesis, and cell division. OTHER INGREDIENTS: Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum, Xylitol.</Description>
</NDC>
<NDC>
<NDCCode>59088-113-66</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (59088-113-66)</PackageDescription>
<NDC11Code>59088-0113-66</NDC11Code>
<ProductNDC>59088-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Purefe Ob Plus</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate And Polysaccharide Iron Complex</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; MAGNESIUM SULFATE, UNSPECIFIED; ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 6.9; 18.2; .8; 1.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-115-60</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (59088-115-60) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59088-0115-60</NDC11Code>
<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>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-210-16</NDCCode>
<PackageDescription>227 g in 1 JAR (59088-210-16) </PackageDescription>
<NDC11Code>59088-0210-16</NDC11Code>
<ProductNDC>59088-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urea 39.5% With 2% Salicylic Acid</ProprietaryName>
<NonProprietaryName>Urea, Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230324</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>UREA; SALICYLIC ACID</SubstanceName>
<StrengthNumber>39.5; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.</IndicationAndUsage>
<Description>Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space. Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of: Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid. Urea is a diamide of carbonic acid with the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>59088-378-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-378-00) * 5 g in 1 TUBE (0168-0357-05) * 1 in 1 BAG (GS1:19555240400625)</PackageDescription>
<NDC11Code>59088-0378-00</NDC11Code>
<ProductNDC>59088-378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venipuncture Cpi</ProprietaryName>
<NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076453</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-660-16</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (59088-660-16) </PackageDescription>
<NDC11Code>59088-0660-16</NDC11Code>
<ProductNDC>59088-660</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Livita Children</ProprietaryName>
<NonProprietaryName>Folate, Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN</SubstanceName>
<StrengthNumber>66.67; 3.33; 300; 66.67; 10; .4; .43; 2.67; .57; 333; .8; 10; .67; 33.33; 1.67; 66.67; 166.67</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.</IndicationAndUsage>
<Description>Serving Size: 15 mL Servings per container: 47. Vitamin A (as Retinyl Acetate)........................ 300 mcg RAE Vitamin C (as Ascorbic Acid)............................... 66.67 mg Vitamin D3 (as Cholecalciferol)............................ 3.33 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............. 10 mg Thiamin (as Thiamine Mononitrate)......................... 0.4 mg Riboflavin .............................................................. 0.43 mg Niacin (as Niacinamide)......................................... 2.67 mg Vitamin B6 (as Pyridoxine Hydrochloride)............. 0.57 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...566 mcg DFE (333 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................... 0.8 mcg Biotin (as D-Biotin)................................................. 10 mcg Pantothenic Acid (as D-Calcium Pantothenate)..... 1.67 mg Choline (as Choline Bitartrate)............................. 66.67 mg Calcium (as Calcium Citrate)............................... 66.67 mg Magnesium (as Magnesium Citrate)...................... 33.3 mg Zinc (as Zinc Picolinate)........................................ 0.67 mg Inulin (as Helianthus Tuberosus Root Extract)... 166.67 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract.</Description>
</NDC>
<NDC>
<NDCCode>59088-771-07</NDCCode>
<PackageDescription>7 g in 1 TUBE (59088-771-07) </PackageDescription>
<NDC11Code>59088-0771-07</NDC11Code>
<ProductNDC>59088-771</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>30; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula. NGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 1% CreamEach gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 1%.</Description>
</NDC>
<NDC>
<NDCCode>59088-771-20</NDCCode>
<PackageDescription>20 TUBE in 1 KIT (59088-771-20) / 7 g in 1 TUBE (59088-771-01) </PackageDescription>
<NDC11Code>59088-0771-20</NDC11Code>
<ProductNDC>59088-771</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>30; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula. NGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 1% CreamEach gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 1%.</Description>
</NDC>
<NDC>
<NDCCode>59088-798-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-798-00) * 1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2) / 150 mL in 1 BOTTLE, DROPPER * 237 mL in 1 BOTTLE, PUMP (59088-310-16) </PackageDescription>
<NDC11Code>59088-0798-00</NDC11Code>
<ProductNDC>59088-798</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lextol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium, Capsaicin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-816-01</NDCCode>
<PackageDescription>7 g in 1 TUBE (59088-816-01) </PackageDescription>
<NDC11Code>59088-0816-01</NDC11Code>
<ProductNDC>59088-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. INGREDIENTS: PharmaPure Rx Lidocaine HCl 2% - Hydrocortisone Acetate 2% Cream. Each gram contains Lidocaine HCl 20 mg, Hydrocortisone Acetate 20 mg. ACTIVE INGREDIENTS. LIDOCAINE HCl 2% HYDROCORTISONE ACETATE 2%.</Description>
</NDC>
<NDC>
<NDCCode>59088-817-01</NDCCode>
<PackageDescription>1 TUBE in 1 KIT (59088-817-01) / 100 g in 1 TUBE (59088-817-07) </PackageDescription>
<NDC11Code>59088-0817-01</NDC11Code>
<ProductNDC>59088-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<ProprietaryNameSuffix>With Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>28; 5.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%.</Description>
</NDC>
<NDC>
<NDCCode>59088-817-07</NDCCode>
<PackageDescription>100 g in 1 TUBE (59088-817-07) </PackageDescription>
<NDC11Code>59088-0817-07</NDC11Code>
<ProductNDC>59088-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<ProprietaryNameSuffix>With Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>28; 5.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%.</Description>
</NDC>
<NDC>
<NDCCode>59088-900-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-900-54) / 14 g in 1 POUCH (59088-900-84) </PackageDescription>
<NDC11Code>59088-0900-54</NDC11Code>
<ProductNDC>59088-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Vii</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan VII is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan VII is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film 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>59088-907-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-907-54) / 14 g in 1 POUCH (59088-907-84) </PackageDescription>
<NDC11Code>59088-0907-54</NDC11Code>
<ProductNDC>59088-907</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Iii</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIDOCAN III is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>LIDOCAN III is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film 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>59088-909-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-909-54) / 14 g in 1 POUCH (59088-909-84) </PackageDescription>
<NDC11Code>59088-0909-54</NDC11Code>
<ProductNDC>59088-909</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan V</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan V is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan V is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film 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>59088-911-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-911-54) / 14 g in 1 POUCH (59088-911-84) </PackageDescription>
<NDC11Code>59088-0911-54</NDC11Code>
<ProductNDC>59088-911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Vi</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan VI is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan VI is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film 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>59088-997-07</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59088-997-07) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0997-07</NDC11Code>
<ProductNDC>59088-997</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.</IndicationAndUsage>
<Description>Contains lidocaine HCl 3% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl). INGREDIENTS: Each gram of PharmaPure Rx Lidocaine HCl 3% Cream contains Lidocaine HCl USP 3%, Inactive ingredients include: Aluminum Sulfate, Calcium Acetate, Cetyl Alcohol, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sodium Hydroxide, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0065-0092-65</NDCCode>
<PackageDescription>12 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00065-0092-65</NDC11Code>
<ProductNDC>0065-0092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorescite</ProprietaryName>
<NonProprietaryName>Fluorescein Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19720915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021980</ApplicationNumber>
<LabelerName>Alcon, Inc.</LabelerName>
<SubstanceName>FLUORESCEIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Diagnostic Dye [EPC], Dyes [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19720915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FLUORESCITE® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.</IndicationAndUsage>
<Description>FLUORESCITE® (fluorescein injection, USP) 10% contains 10% w/v fluorescein. It is a sterile solution for use intravenously as a diagnostic aid. Its chemical name is 3’,6’-dihydroxyspiro[isobenzofuran-1(3H),9’-[9H]xanthene]-3-one. The molecular weight is 332.31 g/mol. The active ingredient is represented by the chemical structure. FLUORESCITE® (fluorescein injection, USP) 10% is supplied as a sterile, unpreserved, unit dose aqueous solution, that has a pH of 8.0 – 9.8 and an osmolality of 572-858 mOsm/kg. Active ingredient: fluorescein sodium. Inactive Ingredients: Sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>0703-4094-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0703-4094-01) / 5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00703-4094-01</NDC11Code>
<ProductNDC>0703-4094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Palonosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180323</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090713</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180323</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Palonosetron hydrochloride injection is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.</IndicationAndUsage>
<Description>Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. Palonosetron hydrochloride exists as a single isomer and has the following structural formula:. C19H24N2OHCl M.W. 332.87. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL single-dose vial. Each 5 mL vial contains 0.25 mg palonosetron base as 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, edetate disodium, trisodium citrate and citric acid in water for intravenous administration. The pH of the solution is 4.5 to 5.5.</Description>
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