{
"NDC": [
{
"NDCCode": "65044-1300-3",
"PackageDescription": "30 mL in 1 VIAL (65044-1300-3) ",
"NDC11Code": "65044-1300-03",
"ProductNDC": "65044-1300",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Pollens - Weeds, Careless/pigweed Mix",
"NonProprietaryName": "Careless/pigweed Mix",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19410419",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103888",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN",
"StrengthNumber": ".05; .05",
"StrengthUnit": "g/mL; g/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19410419",
"SamplePackage": "N",
"IndicationAndUsage": "NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.",
"Description": "Non-standardized allergenic extracts are labeled “No U.S. Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution. Product concentrations vary based on the source. Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents: casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements. Acetone and ether may be used as drying and de-fatting agents. Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas."
},
{
"NDCCode": "65044-1300-2",
"PackageDescription": "10 mL in 1 VIAL (65044-1300-2) ",
"NDC11Code": "65044-1300-02",
"ProductNDC": "65044-1300",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Pollens - Weeds, Careless/pigweed Mix",
"NonProprietaryName": "Careless/pigweed Mix",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19410419",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103888",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN",
"StrengthNumber": ".05; .05",
"StrengthUnit": "g/mL; g/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19410419",
"SamplePackage": "N",
"IndicationAndUsage": "NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.",
"Description": "Non-standardized allergenic extracts are labeled “No U.S. Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution. Product concentrations vary based on the source. Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents: casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements. Acetone and ether may be used as drying and de-fatting agents. Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas."
},
{
"NDCCode": "65044-1300-4",
"PackageDescription": "50 mL in 1 VIAL (65044-1300-4) ",
"NDC11Code": "65044-1300-04",
"ProductNDC": "65044-1300",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Pollens - Weeds, Careless/pigweed Mix",
"NonProprietaryName": "Careless/pigweed Mix",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19410419",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103888",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN",
"StrengthNumber": ".05; .05",
"StrengthUnit": "g/mL; g/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19410419",
"SamplePackage": "N",
"IndicationAndUsage": "NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.",
"Description": "Non-standardized allergenic extracts are labeled “No U.S. Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution. Product concentrations vary based on the source. Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents: casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements. Acetone and ether may be used as drying and de-fatting agents. Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas."
},
{
"NDCCode": "36987-1300-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1300-3)",
"NDC11Code": "36987-1300-03",
"ProductNDC": "36987-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Blackberry",
"NonProprietaryName": "Blackberry",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "BLACKBERRY",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "57841-1300-3",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (57841-1300-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "57841-1300-03",
"ProductNDC": "57841-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Movantik",
"NonProprietaryName": "Naloxegol Oxalate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204760",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "NALOXEGOL OXALATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201001",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "MOVANTIK ®is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.",
"Description": "MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C 34H 53NO 11.C 2H 2O 4and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively, equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black."
},
{
"NDCCode": "57841-1300-4",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (57841-1300-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "57841-1300-04",
"ProductNDC": "57841-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Movantik",
"NonProprietaryName": "Naloxegol Oxalate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204760",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "NALOXEGOL OXALATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201001",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "Y",
"IndicationAndUsage": "MOVANTIK ®is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.",
"Description": "MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C 34H 53NO 11.C 2H 2O 4and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively, equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black."
},
{
"NDCCode": "59762-1300-3",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (59762-1300-3)",
"NDC11Code": "59762-1300-03",
"ProductNDC": "59762-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "Greenstone LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "60541-1300-3",
"PackageDescription": "1 TUBE in 1 CARTON (60541-1300-3) > 30 g in 1 TUBE",
"NDC11Code": "60541-1300-03",
"ProductNDC": "60541-1300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glo Skin Beauty Luxe Liquid Foundation Spf 18",
"NonProprietaryName": "Glo Skin Beauty Luxe Liquid Foundation Spf 18",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Hayden Caleel LLC",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": "10; 5",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20171231",
"SamplePackage": "N"
},
{
"NDCCode": "61995-1300-3",
"PackageDescription": "89 g in 1 TUBE (61995-1300-3) ",
"NDC11Code": "61995-1300-03",
"ProductNDC": "61995-1300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Av3630000 Avalon Organics Eczema Relief Intensive",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170208",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "The Hain Celestial Group, Inc.",
"SubstanceName": "OATMEAL",
"StrengthNumber": "1.5",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170208",
"SamplePackage": "N",
"IndicationAndUsage": "Helps protect and relieve skin irritation and itching due to: Eczema, Rashes, Dry skin."
},
{
"NDCCode": "64536-1948-3",
"PackageDescription": "1300 mL in 1 BOTTLE, PUMP (64536-1948-3) ",
"NDC11Code": "64536-1948-03",
"ProductNDC": "64536-1948",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Care Sentry",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Diversey, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2018-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180219",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For hands to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "64536-3628-3",
"PackageDescription": "1300 mL in 1 BOTTLE, PUMP (64536-3628-3) ",
"NDC11Code": "64536-3628-03",
"ProductNDC": "64536-3628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Care Instant Hand Sanitizer Af",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170414",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diversey, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170414",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For hands to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "64536-8398-3",
"PackageDescription": "1300 mL in 1 BOTTLE, PUMP (64536-8398-3)",
"NDC11Code": "64536-8398-03",
"ProductNDC": "64536-8398",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Care Impact Alcohol Fee Instant Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160914",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Diversey, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "65321-030-03",
"PackageDescription": "3 BAG in 1 BOX (65321-030-03) > 1300 mL in 1 BAG",
"NDC11Code": "65321-0030-03",
"ProductNDC": "65321-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Enrichedfoam",
"ProprietaryNameSuffix": "Alcohol-free Hand Sanitizer",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140410",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Rubbermaid Commercial Products LLC",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140410",
"SamplePackage": "N"
},
{
"NDCCode": "65321-033-03",
"PackageDescription": "3 BAG in 1 BOX (65321-033-03) > 1300 mL in 1 BAG",
"NDC11Code": "65321-0033-03",
"ProductNDC": "65321-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Enriched Foam",
"ProprietaryNameSuffix": "Alcohol-free Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Rubbermaid Commercial Products LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N"
},
{
"NDCCode": "65321-035-01",
"PackageDescription": "3 POUCH in 1 BOX (65321-035-01) > 1300 mL in 1 POUCH",
"NDC11Code": "65321-0035-01",
"ProductNDC": "65321-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tc Enriched Foam Alcohol-free Plus Hand Sanitizer",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191028",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Rubbermaid Commercial Products LLC",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191028",
"SamplePackage": "N"
},
{
"NDCCode": "71335-1300-3",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71335-1300-3) ",
"NDC11Code": "71335-1300-03",
"ProductNDC": "71335-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210432",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190813",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (Octanol : Water) is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange & red capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
},
{
"NDCCode": "0143-9288-01",
"PackageDescription": "1 VIAL in 1 CARTON (0143-9288-01) / 2.5 mL in 1 VIAL",
"NDC11Code": "00143-9288-01",
"ProductNDC": "0143-9288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Argatroban",
"NonProprietaryName": "Argatroban",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120105",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203049",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ARGATROBAN",
"StrengthNumber": "250",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120105",
"SamplePackage": "N",
"IndicationAndUsage": "Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).",
"Description": "Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a sterile clear, colorless to pale yellow, slightly viscous solution. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is available in 250-mg (in 2.5-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 100 mg Argatroban. Inert ingredients (per vial): 1300 mg Propylene glycol, 760 mg Dehydrated alcohol."
},
{
"NDCCode": "0143-9559-01",
"PackageDescription": "1 VIAL in 1 CARTON (0143-9559-01) / 50 mL in 1 VIAL",
"NDC11Code": "00143-9559-01",
"ProductNDC": "0143-9559",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Argatroban",
"NonProprietaryName": "Argatroban",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203049",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ARGATROBAN",
"StrengthNumber": "50",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161101",
"SamplePackage": "N",
"IndicationAndUsage": "Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).",
"Description": "Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a sterile clear, colorless to pale yellow, slightly viscous solution. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is available in 250-mg (in 2.5-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 100 mg Argatroban. Inert ingredients (per vial): 1300 mg Propylene glycol, 760 mg Dehydrated alcohol. Argatroban Injection 50 mg/50 mL (1 mg/mL) is a sterile clear, colorless to pale yellow, solution. Argatroban Injection 50 mg/50 mL (1 mg/mL) is available in 50-mg (in 50-mL) single-dose vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 1 mg Argatroban. Inert ingredients (per vial): 260 mg Propylene glycol, 152 mg Dehydrated alcohol, and 450 mg Sodium Chloride."
},
{
"NDCCode": "0143-9674-01",
"PackageDescription": "2.5 mL in 1 VIAL (0143-9674-01) ",
"NDC11Code": "00143-9674-01",
"ProductNDC": "0143-9674",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Argatroban",
"NonProprietaryName": "Argatroban",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120105",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203049",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ARGATROBAN",
"StrengthNumber": "250",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120105",
"SamplePackage": "N",
"IndicationAndUsage": "Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).",
"Description": "Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a sterile clear, colorless to pale yellow, slightly viscous solution. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is available in 250-mg (in 2.5-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 100 mg Argatroban. Inert ingredients (per vial): 1300 mg Propylene glycol, 760 mg Dehydrated alcohol. Argatroban Injection 50 mg/50 mL (1 mg/mL) is a sterile clear, colorless to pale yellow, solution. Argatroban Injection 50 mg/50 mL (1 mg/mL) is available in 50-mg (in 50-mL) single-dose vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 1 mg Argatroban. Inert ingredients (per vial): 260 mg Propylene glycol, 152 mg Dehydrated alcohol, and 450 mg Sodium Chloride."
},
{
"NDCCode": "0378-1300-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-01) ",
"NDC11Code": "00378-1300-01",
"ProductNDC": "0378-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lithium Carbonate",
"NonProprietaryName": "Lithium Carbonate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120702",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202288",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "LITHIUM CARBONATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120702",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "Lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets are also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.",
"Description": "Lithium carbonate extended-release tablets, USP contain lithium carbonate, USP, a white, granular, odorless powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Each peach, film-coated, extended-release tablet contains 300 mg of lithium carbonate. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of calcium stearate, hypromellose, polydextrose, povidone, polyethylene glycol, red iron oxide, sodium chloride, sodium lauryl sulfate, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Meets USP Dissolution Test 4."
},
{
"NDCCode": "0378-1300-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-05) ",
"NDC11Code": "00378-1300-05",
"ProductNDC": "0378-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lithium Carbonate",
"NonProprietaryName": "Lithium Carbonate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120702",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202288",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "LITHIUM CARBONATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120702",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets are also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.",
"Description": "Lithium carbonate extended-release tablets, USP contain lithium carbonate, USP, a white, granular, odorless powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Each peach, film-coated, extended-release tablet contains 300 mg of lithium carbonate. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of calcium stearate, hypromellose, polydextrose, povidone, polyethylene glycol, red iron oxide, sodium chloride, sodium lauryl sulfate, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Meets USP Dissolution Test 4."
},
{
"NDCCode": "13668-049-13",
"PackageDescription": "1300 TABLET in 1 BOTTLE (13668-049-13) ",
"NDC11Code": "13668-0049-13",
"ProductNDC": "13668-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078947",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090127",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets, USP are supplied for oral administration as 25-mg (white to off white), 100-mg (white to off white), 150-mg (white to off white), and 200-mg (white to off white) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; and sodium starch glycolate. Meets USP Dissolution Test 3."
},
{
"NDCCode": "43742-1300-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1300-1) ",
"NDC11Code": "43742-1300-01",
"ProductNDC": "43742-1300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hormone Combination",
"NonProprietaryName": "Salsolinol (hydrochloride), Cholesterinum, Dhea (dehydroepiandrosterone), 7-oxo- Dehydroepiandrosterone 3-acetate, Folliculinum, Oophorinum (suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180629",
"EndMarketingDate": "20250721",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "7-KETO-DEHYDROEPIANDROSTERONE; ALDOSTERONE; ANDROSTERONE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; FOLLITROPIN; PRASTERONE; PROGESTERONE; SALSOLINOL HYDROCHLORIDE, (+/-)-; SUS SCROFA OVARY; TESTOSTERONE",
"StrengthNumber": "8; 12; 12; 8; 12; 8; 12; 6; 8; 6; 8; 8",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Gonadotropin [EPC], Gonadotropins [CS], Progesterone [CS], Progesterone [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180629",
"EndMarketingDatePackage": "20250721",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of symptoms related to hormone imbalances of insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females), and lack of libido.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "47593-511-62",
"PackageDescription": "1300 mL in 1 BOTTLE, PLASTIC (47593-511-62) ",
"NDC11Code": "47593-0511-62",
"ProductNDC": "47593-511",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ecolab Inc.",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ecolab Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "8.9",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "47593-512-62",
"PackageDescription": "1300 mL in 1 BOTTLE, PLASTIC (47593-512-62) ",
"NDC11Code": "47593-0512-62",
"ProductNDC": "47593-512",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ecolab Inc.",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150302",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ecolab Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "8.9",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150302",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "47593-513-62",
"PackageDescription": "1300 mL in 1 BOTTLE, PLASTIC (47593-513-62) ",
"NDC11Code": "47593-0513-62",
"ProductNDC": "47593-513",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ecolab Inc.",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ecolab Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "8.9",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "47593-514-62",
"PackageDescription": "1300 mL in 1 BOTTLE, PLASTIC (47593-514-62) ",
"NDC11Code": "47593-0514-62",
"ProductNDC": "47593-514",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ecolab Inc.",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150302",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ecolab Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "8.9",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150302",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "50090-1300-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-1300-0) ",
"NDC11Code": "50090-1300-00",
"ProductNDC": "50090-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090494",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel is a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome .",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide."
},
{
"NDCCode": "50090-1300-1",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-1300-1) ",
"NDC11Code": "50090-1300-01",
"ProductNDC": "50090-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090494",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141101",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel is a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome .",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide."
},
{
"NDCCode": "51662-1300-1",
"PackageDescription": "1 BAG in 1 POUCH (51662-1300-1) > 500 mL in 1 BAG",
"NDC11Code": "51662-1300-01",
"ProductNDC": "51662-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Lactate, Potassium Chloride, Calcium Chloride, Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181006",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "20; 30; 600; 310",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181006",
"SamplePackage": "N",
"IndicationAndUsage": "These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.",
"Description": "These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>65044-1300-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL (65044-1300-3) </PackageDescription>
<NDC11Code>65044-1300-03</NDC11Code>
<ProductNDC>65044-1300</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Pollens - Weeds, Careless/pigweed Mix</ProprietaryName>
<NonProprietaryName>Careless/pigweed Mix</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19410419</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103888</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN</SubstanceName>
<StrengthNumber>.05; .05</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19410419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.</IndicationAndUsage>
<Description>Non-standardized allergenic extracts are labeled “No U.S. Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution. Product concentrations vary based on the source. Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents: casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements. Acetone and ether may be used as drying and de-fatting agents. Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas.</Description>
</NDC>
<NDC>
<NDCCode>65044-1300-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-1300-2) </PackageDescription>
<NDC11Code>65044-1300-02</NDC11Code>
<ProductNDC>65044-1300</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Pollens - Weeds, Careless/pigweed Mix</ProprietaryName>
<NonProprietaryName>Careless/pigweed Mix</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19410419</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103888</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN</SubstanceName>
<StrengthNumber>.05; .05</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19410419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.</IndicationAndUsage>
<Description>Non-standardized allergenic extracts are labeled “No U.S. Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution. Product concentrations vary based on the source. Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents: casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements. Acetone and ether may be used as drying and de-fatting agents. Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas.</Description>
</NDC>
<NDC>
<NDCCode>65044-1300-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL (65044-1300-4) </PackageDescription>
<NDC11Code>65044-1300-04</NDC11Code>
<ProductNDC>65044-1300</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Pollens - Weeds, Careless/pigweed Mix</ProprietaryName>
<NonProprietaryName>Careless/pigweed Mix</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19410419</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103888</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN</SubstanceName>
<StrengthNumber>.05; .05</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19410419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.</IndicationAndUsage>
<Description>Non-standardized allergenic extracts are labeled “No U.S. Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution. Product concentrations vary based on the source. Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents: casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements. Acetone and ether may be used as drying and de-fatting agents. Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas.</Description>
</NDC>
<NDC>
<NDCCode>36987-1300-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1300-3)</PackageDescription>
<NDC11Code>36987-1300-03</NDC11Code>
<ProductNDC>36987-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Blackberry</ProprietaryName>
<NonProprietaryName>Blackberry</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>BLACKBERRY</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>57841-1300-3</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (57841-1300-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>57841-1300-03</NDC11Code>
<ProductNDC>57841-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Movantik</ProprietaryName>
<NonProprietaryName>Naloxegol Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204760</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>NALOXEGOL OXALATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MOVANTIK ®is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.</IndicationAndUsage>
<Description>MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C 34H 53NO 11.C 2H 2O 4and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively, equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>57841-1300-4</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (57841-1300-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>57841-1300-04</NDC11Code>
<ProductNDC>57841-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Movantik</ProprietaryName>
<NonProprietaryName>Naloxegol Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204760</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>NALOXEGOL OXALATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MOVANTIK ®is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.</IndicationAndUsage>
<Description>MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C 34H 53NO 11.C 2H 2O 4and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively, equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>59762-1300-3</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (59762-1300-3)</PackageDescription>
<NDC11Code>59762-1300-03</NDC11Code>
<ProductNDC>59762-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>60541-1300-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (60541-1300-3) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>60541-1300-03</NDC11Code>
<ProductNDC>60541-1300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glo Skin Beauty Luxe Liquid Foundation Spf 18</ProprietaryName>
<NonProprietaryName>Glo Skin Beauty Luxe Liquid Foundation Spf 18</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171231</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Hayden Caleel LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>10; 5</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61995-1300-3</NDCCode>
<PackageDescription>89 g in 1 TUBE (61995-1300-3) </PackageDescription>
<NDC11Code>61995-1300-03</NDC11Code>
<ProductNDC>61995-1300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Av3630000 Avalon Organics Eczema Relief Intensive</ProprietaryName>
<NonProprietaryName>Colloidal Oatmeal</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>The Hain Celestial Group, Inc.</LabelerName>
<SubstanceName>OATMEAL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps protect and relieve skin irritation and itching due to: Eczema, Rashes, Dry skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64536-1948-3</NDCCode>
<PackageDescription>1300 mL in 1 BOTTLE, PUMP (64536-1948-3) </PackageDescription>
<NDC11Code>64536-1948-03</NDC11Code>
<ProductNDC>64536-1948</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Care Sentry</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Diversey, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2018-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For hands to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64536-3628-3</NDCCode>
<PackageDescription>1300 mL in 1 BOTTLE, PUMP (64536-3628-3) </PackageDescription>
<NDC11Code>64536-3628-03</NDC11Code>
<ProductNDC>64536-3628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Care Instant Hand Sanitizer Af</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170414</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diversey, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For hands to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64536-8398-3</NDCCode>
<PackageDescription>1300 mL in 1 BOTTLE, PUMP (64536-8398-3)</PackageDescription>
<NDC11Code>64536-8398-03</NDC11Code>
<ProductNDC>64536-8398</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Care Impact Alcohol Fee Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Diversey, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65321-030-03</NDCCode>
<PackageDescription>3 BAG in 1 BOX (65321-030-03) > 1300 mL in 1 BAG</PackageDescription>
<NDC11Code>65321-0030-03</NDC11Code>
<ProductNDC>65321-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Enrichedfoam</ProprietaryName>
<ProprietaryNameSuffix>Alcohol-free Hand Sanitizer</ProprietaryNameSuffix>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140410</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Rubbermaid Commercial Products LLC</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65321-033-03</NDCCode>
<PackageDescription>3 BAG in 1 BOX (65321-033-03) > 1300 mL in 1 BAG</PackageDescription>
<NDC11Code>65321-0033-03</NDC11Code>
<ProductNDC>65321-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Enriched Foam</ProprietaryName>
<ProprietaryNameSuffix>Alcohol-free Hand Sanitizer</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Rubbermaid Commercial Products LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65321-035-01</NDCCode>
<PackageDescription>3 POUCH in 1 BOX (65321-035-01) > 1300 mL in 1 POUCH</PackageDescription>
<NDC11Code>65321-0035-01</NDC11Code>
<ProductNDC>65321-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tc Enriched Foam Alcohol-free Plus Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191028</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Rubbermaid Commercial Products LLC</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-1300-3</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71335-1300-3) </PackageDescription>
<NDC11Code>71335-1300-03</NDC11Code>
<ProductNDC>71335-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210432</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (Octanol : Water) is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange & red capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0143-9288-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0143-9288-01) / 2.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9288-01</NDC11Code>
<ProductNDC>0143-9288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Argatroban</ProprietaryName>
<NonProprietaryName>Argatroban</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120105</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203049</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ARGATROBAN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).</IndicationAndUsage>
<Description>Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a sterile clear, colorless to pale yellow, slightly viscous solution. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is available in 250-mg (in 2.5-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 100 mg Argatroban. Inert ingredients (per vial): 1300 mg Propylene glycol, 760 mg Dehydrated alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0143-9559-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0143-9559-01) / 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9559-01</NDC11Code>
<ProductNDC>0143-9559</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Argatroban</ProprietaryName>
<NonProprietaryName>Argatroban</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203049</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ARGATROBAN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).</IndicationAndUsage>
<Description>Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a sterile clear, colorless to pale yellow, slightly viscous solution. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is available in 250-mg (in 2.5-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 100 mg Argatroban. Inert ingredients (per vial): 1300 mg Propylene glycol, 760 mg Dehydrated alcohol. Argatroban Injection 50 mg/50 mL (1 mg/mL) is a sterile clear, colorless to pale yellow, solution. Argatroban Injection 50 mg/50 mL (1 mg/mL) is available in 50-mg (in 50-mL) single-dose vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 1 mg Argatroban. Inert ingredients (per vial): 260 mg Propylene glycol, 152 mg Dehydrated alcohol, and 450 mg Sodium Chloride.</Description>
</NDC>
<NDC>
<NDCCode>0143-9674-01</NDCCode>
<PackageDescription>2.5 mL in 1 VIAL (0143-9674-01) </PackageDescription>
<NDC11Code>00143-9674-01</NDC11Code>
<ProductNDC>0143-9674</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Argatroban</ProprietaryName>
<NonProprietaryName>Argatroban</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120105</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203049</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ARGATROBAN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).</IndicationAndUsage>
<Description>Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a sterile clear, colorless to pale yellow, slightly viscous solution. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is available in 250-mg (in 2.5-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 100 mg Argatroban. Inert ingredients (per vial): 1300 mg Propylene glycol, 760 mg Dehydrated alcohol. Argatroban Injection 50 mg/50 mL (1 mg/mL) is a sterile clear, colorless to pale yellow, solution. Argatroban Injection 50 mg/50 mL (1 mg/mL) is available in 50-mg (in 50-mL) single-dose vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 1 mg Argatroban. Inert ingredients (per vial): 260 mg Propylene glycol, 152 mg Dehydrated alcohol, and 450 mg Sodium Chloride.</Description>
</NDC>
<NDC>
<NDCCode>0378-1300-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-01) </PackageDescription>
<NDC11Code>00378-1300-01</NDC11Code>
<ProductNDC>0378-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lithium Carbonate</ProprietaryName>
<NonProprietaryName>Lithium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120702</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202288</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LITHIUM CARBONATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120702</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets are also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.</IndicationAndUsage>
<Description>Lithium carbonate extended-release tablets, USP contain lithium carbonate, USP, a white, granular, odorless powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Each peach, film-coated, extended-release tablet contains 300 mg of lithium carbonate. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of calcium stearate, hypromellose, polydextrose, povidone, polyethylene glycol, red iron oxide, sodium chloride, sodium lauryl sulfate, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>0378-1300-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-05) </PackageDescription>
<NDC11Code>00378-1300-05</NDC11Code>
<ProductNDC>0378-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lithium Carbonate</ProprietaryName>
<NonProprietaryName>Lithium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120702</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202288</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LITHIUM CARBONATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120702</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets are also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.</IndicationAndUsage>
<Description>Lithium carbonate extended-release tablets, USP contain lithium carbonate, USP, a white, granular, odorless powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Each peach, film-coated, extended-release tablet contains 300 mg of lithium carbonate. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of calcium stearate, hypromellose, polydextrose, povidone, polyethylene glycol, red iron oxide, sodium chloride, sodium lauryl sulfate, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>13668-049-13</NDCCode>
<PackageDescription>1300 TABLET in 1 BOTTLE (13668-049-13) </PackageDescription>
<NDC11Code>13668-0049-13</NDC11Code>
<ProductNDC>13668-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078947</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets, USP are supplied for oral administration as 25-mg (white to off white), 100-mg (white to off white), 150-mg (white to off white), and 200-mg (white to off white) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; and sodium starch glycolate. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>43742-1300-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1300-1) </PackageDescription>
<NDC11Code>43742-1300-01</NDC11Code>
<ProductNDC>43742-1300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hormone Combination</ProprietaryName>
<NonProprietaryName>Salsolinol (hydrochloride), Cholesterinum, Dhea (dehydroepiandrosterone), 7-oxo- Dehydroepiandrosterone 3-acetate, Folliculinum, Oophorinum (suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180629</StartMarketingDate>
<EndMarketingDate>20250721</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>7-KETO-DEHYDROEPIANDROSTERONE; ALDOSTERONE; ANDROSTERONE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; FOLLITROPIN; PRASTERONE; PROGESTERONE; SALSOLINOL HYDROCHLORIDE, (+/-)-; SUS SCROFA OVARY; TESTOSTERONE</SubstanceName>
<StrengthNumber>8; 12; 12; 8; 12; 8; 12; 6; 8; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Gonadotropin [EPC], Gonadotropins [CS], Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180629</StartMarketingDatePackage>
<EndMarketingDatePackage>20250721</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of symptoms related to hormone imbalances of insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females), and lack of libido.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47593-511-62</NDCCode>
<PackageDescription>1300 mL in 1 BOTTLE, PLASTIC (47593-511-62) </PackageDescription>
<NDC11Code>47593-0511-62</NDC11Code>
<ProductNDC>47593-511</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ecolab Inc.</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ecolab Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>8.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47593-512-62</NDCCode>
<PackageDescription>1300 mL in 1 BOTTLE, PLASTIC (47593-512-62) </PackageDescription>
<NDC11Code>47593-0512-62</NDC11Code>
<ProductNDC>47593-512</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ecolab Inc.</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150302</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ecolab Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>8.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47593-513-62</NDCCode>
<PackageDescription>1300 mL in 1 BOTTLE, PLASTIC (47593-513-62) </PackageDescription>
<NDC11Code>47593-0513-62</NDC11Code>
<ProductNDC>47593-513</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ecolab Inc.</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ecolab Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>8.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47593-514-62</NDCCode>
<PackageDescription>1300 mL in 1 BOTTLE, PLASTIC (47593-514-62) </PackageDescription>
<NDC11Code>47593-0514-62</NDC11Code>
<ProductNDC>47593-514</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ecolab Inc.</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150302</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ecolab Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>8.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-1300-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-1300-0) </PackageDescription>
<NDC11Code>50090-1300-00</NDC11Code>
<ProductNDC>50090-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090494</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel is a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome .</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-1300-1</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-1300-1) </PackageDescription>
<NDC11Code>50090-1300-01</NDC11Code>
<ProductNDC>50090-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090494</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel is a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome .</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>51662-1300-1</NDCCode>
<PackageDescription>1 BAG in 1 POUCH (51662-1300-1) > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>51662-1300-01</NDC11Code>
<ProductNDC>51662-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Lactate, Potassium Chloride, Calcium Chloride, Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181006</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>20; 30; 600; 310</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.</IndicationAndUsage>
<Description>These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.</Description>
</NDC>
</NDCList>