{
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{
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"PackageDescription": "1 BLISTER PACK in 1 CARTON (0781-1681-33) > 3 TABLET, FILM COATED in 1 BLISTER PACK",
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"ProductNDC": "0781-1681",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
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"ApplicationNumber": "ANDA077517",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
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"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077517",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "0781-1681-13",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0781-1681-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
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"ProductNDC": "0781-1681",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Ondansetron",
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"RouteName": "ORAL",
"StartMarketingDate": "20070625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077517",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
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"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
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"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0781-1681-31) ",
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"ApplicationNumber": "ANDA077517",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
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"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070625",
"EndMarketingDatePackage": "20191130",
"SamplePackage": "N"
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{
"NDCCode": "0781-1679-33",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0781-1679-33) > 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00781-1679-33",
"ProductNDC": "0781-1679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
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"DosageFormName": "TABLET, FILM COATED",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077517",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070625",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1941-33",
"PackageDescription": "3 DOSE PACK in 1 CARTON (0781-1941-33) > 3 TABLET, FILM COATED in 1 DOSE PACK",
"NDC11Code": "00781-1941-33",
"ProductNDC": "0781-1941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051114",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065212",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20051114",
"EndMarketingDatePackage": "20200930",
"SamplePackage": "N"
},
{
"NDCCode": "0781-7088-06",
"PackageDescription": "1 BOX in 1 BLISTER PACK (0781-7088-06) > 30 SUPPOSITORY in 1 BOX (0781-7088-33) ",
"NDC11Code": "00781-7088-06",
"ProductNDC": "0781-7088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
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"RouteName": "RECTAL",
"StartMarketingDate": "20191101",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202065",
"LabelerName": "Sandoz Inc",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191101",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
},
{
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"PackageDescription": "30 SUPPOSITORY in 1 BOX (0781-7088-33) ",
"NDC11Code": "00781-7088-33",
"ProductNDC": "0781-7088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20191101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202065",
"LabelerName": "Sandoz Inc",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191101",
"SamplePackage": "N"
},
{
"NDCCode": "37000-781-33",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (37000-781-33)",
"NDC11Code": "37000-0781-33",
"ProductNDC": "37000-781",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Head And Shoulders",
"ProprietaryNameSuffix": "Dry Scalp",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060101",
"EndMarketingDate": "20160224",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Procter & Gamble Manufacturing Co",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2016-02-26"
},
{
"NDCCode": "51991-781-33",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51991-781-33)",
"NDC11Code": "51991-0781-33",
"ProductNDC": "51991-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203390",
"LabelerName": "Breckenridge Pharmaceutical, Inc",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-15"
},
{
"NDCCode": "69423-781-33",
"PackageDescription": "1 TUBE in 1 CARTON (69423-781-33) / 94 g in 1 TUBE",
"NDC11Code": "69423-0781-33",
"ProductNDC": "69423-781",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest",
"ProprietaryNameSuffix": "Pro Health Clean Mint",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221003",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact."
},
{
"NDCCode": "70518-1681-0",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (70518-1681-0) ",
"NDC11Code": "70518-1681-00",
"ProductNDC": "70518-1681",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090695",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181120",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[ b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25 or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue #1. Additionally, the 5 mg capsule contains D&C Red #33, the 10 mg capsule contains D&C Red #33 and D&C Red #28, and the 25 mg capsule contains FD&C Yellow #6. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone."
},
{
"NDCCode": "70518-1681-1",
"PackageDescription": "100 POUCH in 1 BOX (70518-1681-1) / 1 CAPSULE in 1 POUCH (70518-1681-2) ",
"NDC11Code": "70518-1681-01",
"ProductNDC": "70518-1681",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090695",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211011",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[ b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25 or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue #1. Additionally, the 5 mg capsule contains D&C Red #33, the 10 mg capsule contains D&C Red #33 and D&C Red #28, and the 25 mg capsule contains FD&C Yellow #6. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone."
},
{
"NDCCode": "0781-3825-96",
"PackageDescription": "25 VIAL in 1 CARTON (0781-3825-96) / 1 mL in 1 VIAL (0781-3825-71) ",
"NDC11Code": "00781-3825-96",
"ProductNDC": "0781-3825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211334",
"LabelerName": "Sandoz Inc",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).",
"Description": "Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its structural formula is as follows. Molecular Formula: C19H28BrNO3. Molecular Weight: 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. Freely soluble in water, soluble in ethanol (96%). Very slightly soluble in methylene chloride. Practically insoluble in chloroform and in ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C). Glycopyrrolate injection, USP, is intended for intramuscular or intravenous administration. Each 1 mL contains. glycopyrrolate 0.2 mg, water for injection, benzyl alcohol as preservative, and pH adjusted with hydrochloric acid and/or sodium hydroxide as needed."
},
{
"NDCCode": "0781-3827-96",
"PackageDescription": "25 VIAL in 1 CARTON (0781-3827-96) / 2 mL in 1 VIAL (0781-3827-72) ",
"NDC11Code": "00781-3827-96",
"ProductNDC": "0781-3827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211334",
"LabelerName": "Sandoz Inc",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).",
"Description": "Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its structural formula is as follows. Molecular Formula: C19H28BrNO3. Molecular Weight: 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. Freely soluble in water, soluble in ethanol (96%). Very slightly soluble in methylene chloride. Practically insoluble in chloroform and in ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C). Glycopyrrolate injection, USP, is intended for intramuscular or intravenous administration. Each 1 mL contains. glycopyrrolate 0.2 mg, water for injection, benzyl alcohol as preservative, and pH adjusted with hydrochloric acid and/or sodium hydroxide as needed."
},
{
"NDCCode": "0781-3829-96",
"PackageDescription": "25 VIAL in 1 CARTON (0781-3829-96) / 5 mL in 1 VIAL (0781-3829-75) ",
"NDC11Code": "00781-3829-96",
"ProductNDC": "0781-3829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211334",
"LabelerName": "Sandoz Inc",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).",
"Description": "Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its structural formula is as follows. Molecular Formula: C19H28BrNO3. Molecular Weight: 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. Freely soluble in water, soluble in ethanol (96%). Very slightly soluble in methylene chloride. Practically insoluble in chloroform and in ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C). Glycopyrrolate injection, USP, is intended for intramuscular or intravenous administration. Each 1 mL contains. glycopyrrolate 0.2 mg, water for injection, benzyl alcohol as preservative, and pH adjusted with hydrochloric acid and/or sodium hydroxide as needed."
},
{
"NDCCode": "0781-3831-95",
"PackageDescription": "10 VIAL in 1 CARTON (0781-3831-95) / 20 mL in 1 VIAL (0781-3831-80) ",
"NDC11Code": "00781-3831-95",
"ProductNDC": "0781-3831",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211334",
"LabelerName": "Sandoz Inc",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).",
"Description": "Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its structural formula is as follows. Molecular Formula: C19H28BrNO3. Molecular Weight: 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. Freely soluble in water, soluble in ethanol (96%). Very slightly soluble in methylene chloride. Practically insoluble in chloroform and in ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C). Glycopyrrolate injection, USP, is intended for intramuscular or intravenous administration. Each 1 mL contains. glycopyrrolate 0.2 mg, water for injection, benzyl alcohol as preservative, and pH adjusted with hydrochloric acid and/or sodium hydroxide as needed."
},
{
"NDCCode": "16571-781-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16571-781-01) ",
"NDC11Code": "16571-0781-01",
"ProductNDC": "16571-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040792",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090806",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].",
"Description": "Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "16571-781-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-781-10) ",
"NDC11Code": "16571-0781-10",
"ProductNDC": "16571-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040792",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090806",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].",
"Description": "Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "16571-781-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-781-50) ",
"NDC11Code": "16571-0781-50",
"ProductNDC": "16571-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040792",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090806",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].",
"Description": "Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "50474-781-84",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50474-781-84) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50474-0781-84",
"ProductNDC": "50474-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimzelx",
"NonProprietaryName": "Bimekizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231017",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761151",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BIMEKIZUMAB",
"StrengthNumber": "160",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241001",
"SamplePackage": "N",
"IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
},
{
"NDCCode": "50474-781-85",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (50474-781-85) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50474-0781-85",
"ProductNDC": "50474-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimzelx",
"NonProprietaryName": "Bimekizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231017",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761151",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BIMEKIZUMAB",
"StrengthNumber": "160",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231017",
"SamplePackage": "N",
"IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
},
{
"NDCCode": "50474-781-86",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50474-781-86) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50474-0781-86",
"ProductNDC": "50474-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimzelx",
"NonProprietaryName": "Bimekizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231017",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761151",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BIMEKIZUMAB",
"StrengthNumber": "160",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241001",
"SamplePackage": "N",
"IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
},
{
"NDCCode": "50474-781-87",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (50474-781-87) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "50474-0781-87",
"ProductNDC": "50474-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimzelx",
"NonProprietaryName": "Bimekizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231017",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761151",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BIMEKIZUMAB",
"StrengthNumber": "160",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231017",
"SamplePackage": "N",
"IndicationAndUsage": "BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .",
"Description": "Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1."
},
{
"NDCCode": "51407-781-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (51407-781-60) ",
"NDC11Code": "51407-0781-60",
"ProductNDC": "51407-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eslicarbazepine Acetate",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211236",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250512",
"SamplePackage": "N",
"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate is (10S)-10-(Acetoxy)-10, 11-dihydro-5Hdibenz [b, f]azepine-5-carboxamide. Eslicarbazepine acetate tablets are a dibenz [b, f] azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.33 g/mol. The chemical structure is:. Eslicarbazepine acetate is a white to almost white crystalline powder. It is freely soluble in dimethyl sulfoxide and dichloromethane, and soluble in acetonitrile. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg and 800 mg of eslicarbazepine acetate and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "63824-781-74",
"PackageDescription": "118 mL in 1 BOTTLE (63824-781-74) ",
"NDC11Code": "63824-0781-74",
"ProductNDC": "63824-781",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cepacol",
"ProprietaryNameSuffix": "Sore Throat",
"NonProprietaryName": "Dyclonine Hydrochloride And Glycerin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110520",
"EndMarketingDate": "20240901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "RB Health (US) LLC",
"SubstanceName": "DYCLONINE HYDROCHLORIDE; GLYCERIN",
"StrengthNumber": ".1; 33",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110520",
"EndMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of: 1 occasional minor irritation, pain, sore mouth, and sore throat, 2 pain associated with canker sores, 3 minor discomfort and protection of irritated areas in sore mouth and sore throat."
},
{
"NDCCode": "66993-781-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-781-30) ",
"NDC11Code": "66993-0781-30",
"ProductNDC": "66993-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine And Topiramate",
"NonProprietaryName": "Phentermine And Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022580",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE; TOPIRAMATE",
"StrengthNumber": "7.5; 46",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adults and pediatric patients aged 12 years and older with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride (expressed as the weight of the free base) and extended-release topiramate. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, a sympathomimetic amine anorectic, and topiramate, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride. The chemical name of phentermine hydrochloride is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C 10H 15N HCl and its molecular weight is 185.7 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder that is soluble in water, methanol, and ethanol. Its structural formula is:. Topiramate. Topiramate is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C 12H 21NO 8S and its molecular weight is 339.4. Topiramate is a white to off-white crystalline powder with a bitter taste. It is freely soluble in methanol and acetone, sparingly soluble in pH 9 to pH 12 aqueous solutions and slightly soluble in pH 1 to pH 8 aqueous solutions. Its structural formula is:. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths: 1 3.75 mg/23 mg (phentermine 3.75 mg and topiramate 23 mg) (equivalent to 4.67 mg of Phentermine Hydrochloride USP)., 2 7.5 mg/46 mg (phentermine 7.5 mg and topiramate 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride USP)., 3 11.25 mg/69 mg (phentermine 11.25 mg and topiramate 69 mg) (equivalent to 14.0 mg of Phentermine Hydrochloride USP)., 4 15 mg/92 mg (phentermine 15 mg and topiramate 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride USP)."
},
{
"NDCCode": "0115-1681-26",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (0115-1681-26) / 1 TABLET in 1 BLISTER PACK (0115-1681-30) ",
"NDC11Code": "00115-1681-26",
"ProductNDC": "0115-1681",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075710",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080206",
"SamplePackage": "N",
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"Description": "Alendronate Sodium Tablets, USP is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium, USP is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The structural formula is. C4H12NNaO7P23H2O M.W. 325.12. Alendronate sodium, USP is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet for oral administration contains 6.53, 13.05, 45.68, 52.21 or 91.36 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Alendronate Sodium Tablets, USP meet USP Dissolution Test 2."
},
{
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"Description": "Alendronate Sodium Tablets, USP is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium, USP is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The structural formula is. C4H12NNaO7P23H2O M.W. 325.12. Alendronate sodium, USP is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet for oral administration contains 6.53, 13.05, 45.68, 52.21 or 91.36 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Alendronate Sodium Tablets, USP meet USP Dissolution Test 2."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Lannett Company, Inc.",
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}
]
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<StrengthUnit>mg/1</StrengthUnit>
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<LabelerName>Sandoz Inc</LabelerName>
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<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<LabelerName>Sandoz Inc</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070625</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0781-1941-33</NDCCode>
<PackageDescription>3 DOSE PACK in 1 CARTON (0781-1941-33) > 3 TABLET, FILM COATED in 1 DOSE PACK</PackageDescription>
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<ProprietaryName>Azithromycin</ProprietaryName>
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<ApplicationNumber>ANDA065212</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<ApplicationNumber>ANDA202065</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<Status>Deprecated</Status>
<LastUpdate>2020-02-07</LastUpdate>
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<EndMarketingDate>20160224</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Co</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
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<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-02-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>51991-781-33</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
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<LastUpdate>2017-11-15</LastUpdate>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.</IndicationAndUsage>
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<ProductNDC>70518-1681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090695</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
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<LastUpdate>2026-07-10</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[ b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25 or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue #1. Additionally, the 5 mg capsule contains D&C Red #33, the 10 mg capsule contains D&C Red #33 and D&C Red #28, and the 25 mg capsule contains FD&C Yellow #6. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone.</Description>
</NDC>
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<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2024-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[ b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25 or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue #1. Additionally, the 5 mg capsule contains D&C Red #33, the 10 mg capsule contains D&C Red #33 and D&C Red #28, and the 25 mg capsule contains FD&C Yellow #6. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone.</Description>
</NDC>
<NDC>
<NDCCode>0781-3825-96</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (0781-3825-96) / 1 mL in 1 VIAL (0781-3825-71) </PackageDescription>
<NDC11Code>00781-3825-96</NDC11Code>
<ProductNDC>0781-3825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211334</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).</IndicationAndUsage>
<Description>Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its structural formula is as follows. Molecular Formula: C19H28BrNO3. Molecular Weight: 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. Freely soluble in water, soluble in ethanol (96%). Very slightly soluble in methylene chloride. Practically insoluble in chloroform and in ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C). Glycopyrrolate injection, USP, is intended for intramuscular or intravenous administration. Each 1 mL contains. glycopyrrolate 0.2 mg, water for injection, benzyl alcohol as preservative, and pH adjusted with hydrochloric acid and/or sodium hydroxide as needed.</Description>
</NDC>
<NDC>
<NDCCode>0781-3827-96</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (0781-3827-96) / 2 mL in 1 VIAL (0781-3827-72) </PackageDescription>
<NDC11Code>00781-3827-96</NDC11Code>
<ProductNDC>0781-3827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211334</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).</IndicationAndUsage>
<Description>Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its structural formula is as follows. Molecular Formula: C19H28BrNO3. Molecular Weight: 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. Freely soluble in water, soluble in ethanol (96%). Very slightly soluble in methylene chloride. Practically insoluble in chloroform and in ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C). Glycopyrrolate injection, USP, is intended for intramuscular or intravenous administration. Each 1 mL contains. glycopyrrolate 0.2 mg, water for injection, benzyl alcohol as preservative, and pH adjusted with hydrochloric acid and/or sodium hydroxide as needed.</Description>
</NDC>
<NDC>
<NDCCode>0781-3829-96</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (0781-3829-96) / 5 mL in 1 VIAL (0781-3829-75) </PackageDescription>
<NDC11Code>00781-3829-96</NDC11Code>
<ProductNDC>0781-3829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211334</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).</IndicationAndUsage>
<Description>Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its structural formula is as follows. Molecular Formula: C19H28BrNO3. Molecular Weight: 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. Freely soluble in water, soluble in ethanol (96%). Very slightly soluble in methylene chloride. Practically insoluble in chloroform and in ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C). Glycopyrrolate injection, USP, is intended for intramuscular or intravenous administration. Each 1 mL contains. glycopyrrolate 0.2 mg, water for injection, benzyl alcohol as preservative, and pH adjusted with hydrochloric acid and/or sodium hydroxide as needed.</Description>
</NDC>
<NDC>
<NDCCode>0781-3831-95</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0781-3831-95) / 20 mL in 1 VIAL (0781-3831-80) </PackageDescription>
<NDC11Code>00781-3831-95</NDC11Code>
<ProductNDC>0781-3831</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211334</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate injection is an anticholinergic indicated. in anesthesia (adult and pediatric patients): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation., 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias., 3 for protection against peripheral muscarinic effects of cholinergic agents. (1).</IndicationAndUsage>
<Description>Glycopyrrolate is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its structural formula is as follows. Molecular Formula: C19H28BrNO3. Molecular Weight: 398.33. Glycopyrrolate occurs as a white, odorless crystalline powder. Freely soluble in water, soluble in ethanol (96%). Very slightly soluble in methylene chloride. Practically insoluble in chloroform and in ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C). Glycopyrrolate injection, USP, is intended for intramuscular or intravenous administration. Each 1 mL contains. glycopyrrolate 0.2 mg, water for injection, benzyl alcohol as preservative, and pH adjusted with hydrochloric acid and/or sodium hydroxide as needed.</Description>
</NDC>
<NDC>
<NDCCode>16571-781-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16571-781-01) </PackageDescription>
<NDC11Code>16571-0781-01</NDC11Code>
<ProductNDC>16571-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040792</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>16571-781-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16571-781-10) </PackageDescription>
<NDC11Code>16571-0781-10</NDC11Code>
<ProductNDC>16571-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040792</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>16571-781-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-781-50) </PackageDescription>
<NDC11Code>16571-0781-50</NDC11Code>
<ProductNDC>16571-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040792</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>50474-781-84</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50474-781-84) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50474-0781-84</NDC11Code>
<ProductNDC>50474-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimzelx</ProprietaryName>
<NonProprietaryName>Bimekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231017</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761151</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BIMEKIZUMAB</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .</IndicationAndUsage>
<Description>Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.</Description>
</NDC>
<NDC>
<NDCCode>50474-781-85</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (50474-781-85) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50474-0781-85</NDC11Code>
<ProductNDC>50474-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimzelx</ProprietaryName>
<NonProprietaryName>Bimekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231017</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761151</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BIMEKIZUMAB</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .</IndicationAndUsage>
<Description>Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.</Description>
</NDC>
<NDC>
<NDCCode>50474-781-86</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50474-781-86) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50474-0781-86</NDC11Code>
<ProductNDC>50474-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimzelx</ProprietaryName>
<NonProprietaryName>Bimekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231017</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761151</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BIMEKIZUMAB</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .</IndicationAndUsage>
<Description>Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.</Description>
</NDC>
<NDC>
<NDCCode>50474-781-87</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (50474-781-87) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>50474-0781-87</NDC11Code>
<ProductNDC>50474-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimzelx</ProprietaryName>
<NonProprietaryName>Bimekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231017</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761151</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BIMEKIZUMAB</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .</IndicationAndUsage>
<Description>Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.</Description>
</NDC>
<NDC>
<NDCCode>51407-781-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (51407-781-60) </PackageDescription>
<NDC11Code>51407-0781-60</NDC11Code>
<ProductNDC>51407-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211236</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate is (10S)-10-(Acetoxy)-10, 11-dihydro-5Hdibenz [b, f]azepine-5-carboxamide. Eslicarbazepine acetate tablets are a dibenz [b, f] azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.33 g/mol. The chemical structure is:. Eslicarbazepine acetate is a white to almost white crystalline powder. It is freely soluble in dimethyl sulfoxide and dichloromethane, and soluble in acetonitrile. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg and 800 mg of eslicarbazepine acetate and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>63824-781-74</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (63824-781-74) </PackageDescription>
<NDC11Code>63824-0781-74</NDC11Code>
<ProductNDC>63824-781</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cepacol</ProprietaryName>
<ProprietaryNameSuffix>Sore Throat</ProprietaryNameSuffix>
<NonProprietaryName>Dyclonine Hydrochloride And Glycerin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110520</StartMarketingDate>
<EndMarketingDate>20240901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>RB Health (US) LLC</LabelerName>
<SubstanceName>DYCLONINE HYDROCHLORIDE; GLYCERIN</SubstanceName>
<StrengthNumber>.1; 33</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110520</StartMarketingDatePackage>
<EndMarketingDatePackage>20240901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of: 1 occasional minor irritation, pain, sore mouth, and sore throat, 2 pain associated with canker sores, 3 minor discomfort and protection of irritated areas in sore mouth and sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66993-781-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-781-30) </PackageDescription>
<NDC11Code>66993-0781-30</NDC11Code>
<ProductNDC>66993-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine And Topiramate</ProprietaryName>
<NonProprietaryName>Phentermine And Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022580</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE; TOPIRAMATE</SubstanceName>
<StrengthNumber>7.5; 46</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adults and pediatric patients aged 12 years and older with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride (expressed as the weight of the free base) and extended-release topiramate. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, a sympathomimetic amine anorectic, and topiramate, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride. The chemical name of phentermine hydrochloride is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C 10H 15N HCl and its molecular weight is 185.7 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder that is soluble in water, methanol, and ethanol. Its structural formula is:. Topiramate. Topiramate is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C 12H 21NO 8S and its molecular weight is 339.4. Topiramate is a white to off-white crystalline powder with a bitter taste. It is freely soluble in methanol and acetone, sparingly soluble in pH 9 to pH 12 aqueous solutions and slightly soluble in pH 1 to pH 8 aqueous solutions. Its structural formula is:. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths: 1 3.75 mg/23 mg (phentermine 3.75 mg and topiramate 23 mg) (equivalent to 4.67 mg of Phentermine Hydrochloride USP)., 2 7.5 mg/46 mg (phentermine 7.5 mg and topiramate 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride USP)., 3 11.25 mg/69 mg (phentermine 11.25 mg and topiramate 69 mg) (equivalent to 14.0 mg of Phentermine Hydrochloride USP)., 4 15 mg/92 mg (phentermine 15 mg and topiramate 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride USP).</Description>
</NDC>
<NDC>
<NDCCode>0115-1681-26</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (0115-1681-26) / 1 TABLET in 1 BLISTER PACK (0115-1681-30) </PackageDescription>
<NDC11Code>00115-1681-26</NDC11Code>
<ProductNDC>0115-1681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075710</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium tablets are a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate Sodium Tablets, USP is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium, USP is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The structural formula is. C4H12NNaO7P23H2O M.W. 325.12. Alendronate sodium, USP is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet for oral administration contains 6.53, 13.05, 45.68, 52.21 or 91.36 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Alendronate Sodium Tablets, USP meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0115-1681-34</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0115-1681-34) / 1 TABLET in 1 BLISTER PACK (0115-1681-30) </PackageDescription>
<NDC11Code>00115-1681-34</NDC11Code>
<ProductNDC>0115-1681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075710</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium tablets are a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate Sodium Tablets, USP is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium, USP is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The structural formula is. C4H12NNaO7P23H2O M.W. 325.12. Alendronate sodium, USP is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet for oral administration contains 6.53, 13.05, 45.68, 52.21 or 91.36 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Alendronate Sodium Tablets, USP meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0527-1681-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0527-1681-01) </PackageDescription>
<NDC11Code>00527-1681-01</NDC11Code>
<ProductNDC>0527-1681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobazam</ProprietaryName>
<NonProprietaryName>Clobazam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212092</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>CLOBAZAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>