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"ProductTypeName": "HUMAN OTC DRUG",
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"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:nasal congestionheadachecoughminor aches and painssore throat. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
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{
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"PackageDescription": "14 g in 1 CYLINDER (37000-197-14) ",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gillette Endurance Cool Wave Clear",
"NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
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{
"NDCCode": "51013-170-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-170-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN OTC DRUG",
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"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
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"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:nasal congestioncoughheadacheminor aches & painssinus congestion & pressure. temporarily reduces fever. temporarily promotes nasal and/or sinus drainage."
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{
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"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-171-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
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"ProductNDC": "51013-171",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Night Time Cold And Flu Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
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"LabelerName": "PuraCap Pharmaceutical LLC",
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"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160610",
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{
"NDCCode": "51013-183-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-183-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0183-14",
"ProductNDC": "51013-183",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160715",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
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"LastUpdate": "2025-01-01",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160715",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 cough due to minor throat & bronchial irritation, 3 sore throat, 4 headache, 5 minor aches & pains, 6 fever."
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{
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"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-184-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0184-14",
"ProductNDC": "51013-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nitetime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160718",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
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"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
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"LastUpdate": "2025-01-01",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160718",
"SamplePackage": "N",
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{
"NDCCode": "51013-185-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-185-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0185-14",
"ProductNDC": "51013-185",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Day Time Sinus Relief",
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"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160714",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1; mg/1",
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"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160714",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves sinus symptoms: 1 sinus pain, 2 headache, 3 nasal & sinus congestion."
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{
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"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-186-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0186-14",
"ProductNDC": "51013-186",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night Time Sinus Relief",
"NonProprietaryName": "Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160715",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
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"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160715",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal and sinus symptoms: 1 sinus pain , 2 headache, 3 nasal and sinus congestion, 4 runny nose and sneezing."
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{
"NDCCode": "51013-191-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-191-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0191-14",
"ProductNDC": "51013-191",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Flu And Sore Throat Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170714",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
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"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
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"LastUpdate": "2025-01-01",
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"ProductNdcExcludeFlag": "N",
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{
"NDCCode": "51013-192-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-192-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0192-14",
"ProductNDC": "51013-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Severe Sinus Congestion Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20170714",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
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"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170714",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves:."
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{
"NDCCode": "51013-193-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-193-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0193-14",
"ProductNDC": "51013-193",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20170714",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
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"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:. cough. nasal congestion. minor aches and pains. sore throat. headache. runny nose. sneezing. temporarily reduces fever. controls cough to help you get to sleep."
},
{
"NDCCode": "51013-198-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-198-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0198-14",
"ProductNDC": "51013-198",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Severe Sinus Congestion Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170712",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
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"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170712",
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},
{
"NDCCode": "51013-409-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-409-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0409-14",
"ProductNDC": "51013-409",
"ProductTypeName": "HUMAN OTC DRUG",
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"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170523",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
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"Status": "Deprecated",
"LastUpdate": "2025-01-01",
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"StartMarketingDatePackage": "20170523",
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},
{
"NDCCode": "51013-415-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-415-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0415-14",
"ProductNDC": "51013-415",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Flu And Sore Throat Relief",
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"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170829",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
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"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
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},
{
"NDCCode": "51013-417-14",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-417-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0417-14",
"ProductNDC": "51013-417",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Severe Sinus Congestion Relief",
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"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170829",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
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"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170829",
"SamplePackage": "N",
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},
{
"NDCCode": "33342-197-57",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57) ",
"NDC11Code": "33342-0197-57",
"ProductNDC": "33342-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colesevelam Hydrochloride",
"NonProprietaryName": "Colesevelam Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204893",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "COLESEVELAM HYDROCHLORIDE",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250418",
"SamplePackage": "N",
"IndicationAndUsage": "Colesevelam hydrochloride tablets are a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1). reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1). improve glycemic control in adults with type 2 diabetes mellitus (1.2). Limitations of Use (1.3): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias.",
"Description": "Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is 1-Hexaminium, N,N,N-Trimethyl-6-(2-propenylamino)-, chloride, polymer with (chloromethyl) oxirane, 2-propen-4-amine and N-2-propenyl-1-decanamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethyl ammonium) hexyl group, and m represents a number ≥100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablets are white to off white, capsule shaped biconvex film coated tablet, imprinted with “L56” on one side and free from physical defects, containing 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, diacetylated monoglycerides, hypromellose, magnesium stearate, microcrystalline cellulose. The tablets are imprinted using ammonium hydroxide, black iron oxide, propylene glycol, shellac."
},
{
"NDCCode": "49349-197-02",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49349-197-02)",
"NDC11Code": "49349-0197-02",
"ProductNDC": "49349-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium Delayed Release",
"NonProprietaryName": "Divalproex Sodium Delayed Release",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078597",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-03-14"
},
{
"NDCCode": "49349-197-24",
"PackageDescription": "200 TABLET, DELAYED RELEASE in 1 CANISTER (49349-197-24)",
"NDC11Code": "49349-0197-24",
"ProductNDC": "49349-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium Delayed Release",
"NonProprietaryName": "Divalproex Sodium Delayed Release",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078597",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-03-14"
},
{
"NDCCode": "50242-125-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50242-0125-01",
"ProductNDC": "50242-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Columvi",
"NonProprietaryName": "Glofitamab",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761309",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "GLOFITAMAB",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230615",
"SamplePackage": "N",
"IndicationAndUsage": "COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager. It is a recombinant humanized anti-CD20 anti-CD3ɛ bispecific immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese hamster ovary (CHO) cells. Glofitamab-gxbm has an approximate molecular weight of 197 kDa. COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution supplied in single-dose vials for intravenous infusion. COLUMVI is supplied in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials at a concentration of 1 mg/mL. Each mL of solution contains 1 mg glofitamab-gxbm, histidine (0.63 mg), histidine hydrochloride monohydrate (3.34 mg), methionine (1.49 mg), polysorbate 20 (0.5 mg), sucrose (82.15 mg), and Water for Injection, USP, at pH 5.5."
},
{
"NDCCode": "50242-127-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50242-0127-01",
"ProductNDC": "50242-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Columvi",
"NonProprietaryName": "Glofitamab",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761309",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "GLOFITAMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230615",
"SamplePackage": "N",
"IndicationAndUsage": "COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager. It is a recombinant humanized anti-CD20 anti-CD3ɛ bispecific immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese hamster ovary (CHO) cells. Glofitamab-gxbm has an approximate molecular weight of 197 kDa. COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution supplied in single-dose vials for intravenous infusion. COLUMVI is supplied in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials at a concentration of 1 mg/mL. Each mL of solution contains 1 mg glofitamab-gxbm, histidine (0.63 mg), histidine hydrochloride monohydrate (3.34 mg), methionine (1.49 mg), polysorbate 20 (0.5 mg), sucrose (82.15 mg), and Water for Injection, USP, at pH 5.5."
},
{
"NDCCode": "55150-197-20",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0197-20",
"ProductNDC": "55150-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20160915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205612",
"LabelerName": "Eugia US LLC",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160915",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride, USP is chemically described as S-(-)-1-propyl-2’,6’-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. ' C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "60687-661-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-661-01) / 1 TABLET in 1 BLISTER PACK (60687-661-11) ",
"NDC11Code": "60687-0661-01",
"ProductNDC": "60687-661",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074260",
"LabelerName": "American Health Packaging",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220527",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths: 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake."
},
{
"NDCCode": "60687-836-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-836-01) / 1 TABLET in 1 BLISTER PACK (60687-836-11) ",
"NDC11Code": "60687-0836-01",
"ProductNDC": "60687-836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074260",
"LabelerName": "American Health Packaging",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240316",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths: 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake."
},
{
"NDCCode": "67046-1689-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-1689-3) ",
"NDC11Code": "67046-1689-03",
"ProductNDC": "67046-1689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216537",
"LabelerName": "Coupler LLC",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260713",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3N hydrochloric acid, slightly soluble in water and methanol, practically insoluble in alcohol, acetone, ether and chloroform, with a molecular weight of 244.3. It is designated chemically as (—)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3N hydrochloric acid, insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (—)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa is supplied as tablets for oral administration in three strengths. Carbidopa and levodopa tablets USP, 25 mg/100 mg containing 25 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets USP, 10 mg/100 mg containing 10 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets USP, 25 mg/250 mg containing 25 mg of carbidopa USP and 250 mg of levodopa USP. Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). Carbidopa and levodopa tablets USP, 10 mg/100 mg and 25 mg/250 mg also contain FD&C Blue No.2 Aluminum Lake. Carbidopa and levodopa tablets USP, 25 mg/100 mg also contain D&C Yellow No.10. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70710-2139-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-2139-1) ",
"NDC11Code": "70710-2139-01",
"ProductNDC": "70710-2139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA203312",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "23.75; 95",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release capsules are indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4 H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "70710-2140-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-2140-1) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
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"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA203312",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
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"IndicationAndUsage": "Carbidopa and levodopa extended-release capsules are indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4 H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "70710-2141-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-2141-1) ",
"NDC11Code": "70710-2141-01",
"ProductNDC": "70710-2141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA203312",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "48.75; 195",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251020",
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"IndicationAndUsage": "Carbidopa and levodopa extended-release capsules are indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4 H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "70710-2142-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-2142-1) ",
"NDC11Code": "70710-2142-01",
"ProductNDC": "70710-2142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA203312",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "61.25; 245",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20251020",
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"IndicationAndUsage": "Carbidopa and levodopa extended-release capsules are indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4 H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "72888-155-00",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-00) ",
"NDC11Code": "72888-0155-00",
"ProductNDC": "72888-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217482",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240604",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release tablets, USP are extended-release oral dosage form and are combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-α-hydrazino- α -methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L- α -amino- β -(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide. Carbidopa and levodopa extended-release tablets, USP 25 mg/100 mg and 50 mg/ 200 mg also contain FD&C red 40 Alu lake and FD&C blue 2 Alu lake. The 25 mg/100 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ50” on one side and plain on other. The 50 mg/200 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ51” on one side and plain on other. The carbidopa and levodopa extended-release tablets are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablets 25 mg/100 mg are available to facilitate titration when 100 mg steps are required. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72888-155-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-01) ",
"NDC11Code": "72888-0155-01",
"ProductNDC": "72888-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217482",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240604",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release tablets, USP are extended-release oral dosage form and are combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-α-hydrazino- α -methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L- α -amino- β -(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide. Carbidopa and levodopa extended-release tablets, USP 25 mg/100 mg and 50 mg/ 200 mg also contain FD&C red 40 Alu lake and FD&C blue 2 Alu lake. The 25 mg/100 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ50” on one side and plain on other. The 50 mg/200 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ51” on one side and plain on other. The carbidopa and levodopa extended-release tablets are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablets 25 mg/100 mg are available to facilitate titration when 100 mg steps are required. FDA approved dissolution test specifications differ from USP."
}
]
}
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<ProprietaryName>Gillette Endurance Cool Wave Clear</ProprietaryName>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-171-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
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<IndicationAndUsage>temporarily relieves these common cold and flu symptoms:. nasal congestion. cough. headache. sore throat. minor aches & pains. runny nose. sneezing.</IndicationAndUsage>
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<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 cough due to minor throat & bronchial irritation, 2 sore throat, 3 headache, 4 minor aches & pains, 5 fever, 6 runny nose & sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51013-185-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-185-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0185-14</NDC11Code>
<ProductNDC>51013-185</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Day Time Sinus Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160714</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves sinus symptoms: 1 sinus pain, 2 headache, 3 nasal & sinus congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51013-186-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-186-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0186-14</NDC11Code>
<ProductNDC>51013-186</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Night Time Sinus Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 6.25; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal and sinus symptoms: 1 sinus pain , 2 headache, 3 nasal and sinus congestion, 4 runny nose and sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51013-191-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-191-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0191-14</NDC11Code>
<ProductNDC>51013-191</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold Flu And Sore Throat Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170714</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves:nasal congestionheadachecoughminor aches and painssore throat. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51013-192-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-192-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0192-14</NDC11Code>
<ProductNDC>51013-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Severe Sinus Congestion Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170714</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves:.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51013-193-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-193-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0193-14</NDC11Code>
<ProductNDC>51013-193</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170714</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 6.25; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms:. cough. nasal congestion. minor aches and pains. sore throat. headache. runny nose. sneezing. temporarily reduces fever. controls cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51013-198-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-198-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0198-14</NDC11Code>
<ProductNDC>51013-198</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Severe Sinus Congestion Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170712</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves:.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51013-409-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-409-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0409-14</NDC11Code>
<ProductNDC>51013-409</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex Fast-max Severe Cold</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170523</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms:. nasal congestion. headache. cough. minor aches and pains. sore throat. temperarily reduces fever. promotes nasal and/or sinus drainage. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51013-415-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-415-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0415-14</NDC11Code>
<ProductNDC>51013-415</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold Flu And Sore Throat Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170829</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves:nasal congestionheadachecoughminor aches and painssore throat. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51013-417-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-417-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0417-14</NDC11Code>
<ProductNDC>51013-417</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Severe Sinus Congestion Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170829</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves:.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-197-57</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57) </PackageDescription>
<NDC11Code>33342-0197-57</NDC11Code>
<ProductNDC>33342-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colesevelam Hydrochloride</ProprietaryName>
<NonProprietaryName>Colesevelam Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204893</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colesevelam hydrochloride tablets are a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1). reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1). improve glycemic control in adults with type 2 diabetes mellitus (1.2). Limitations of Use (1.3): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias.</IndicationAndUsage>
<Description>Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is 1-Hexaminium, N,N,N-Trimethyl-6-(2-propenylamino)-, chloride, polymer with (chloromethyl) oxirane, 2-propen-4-amine and N-2-propenyl-1-decanamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethyl ammonium) hexyl group, and m represents a number ≥100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablets are white to off white, capsule shaped biconvex film coated tablet, imprinted with “L56” on one side and free from physical defects, containing 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, diacetylated monoglycerides, hypromellose, magnesium stearate, microcrystalline cellulose. The tablets are imprinted using ammonium hydroxide, black iron oxide, propylene glycol, shellac.</Description>
</NDC>
<NDC>
<NDCCode>49349-197-02</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49349-197-02)</PackageDescription>
<NDC11Code>49349-0197-02</NDC11Code>
<ProductNDC>49349-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium Delayed Release</ProprietaryName>
<NonProprietaryName>Divalproex Sodium Delayed Release</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078597</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-14</LastUpdate>
</NDC>
<NDC>
<NDCCode>49349-197-24</NDCCode>
<PackageDescription>200 TABLET, DELAYED RELEASE in 1 CANISTER (49349-197-24)</PackageDescription>
<NDC11Code>49349-0197-24</NDC11Code>
<ProductNDC>49349-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium Delayed Release</ProprietaryName>
<NonProprietaryName>Divalproex Sodium Delayed Release</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078597</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-14</LastUpdate>
</NDC>
<NDC>
<NDCCode>50242-125-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50242-0125-01</NDC11Code>
<ProductNDC>50242-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Columvi</ProprietaryName>
<NonProprietaryName>Glofitamab</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761309</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>GLOFITAMAB</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager. It is a recombinant humanized anti-CD20 anti-CD3ɛ bispecific immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese hamster ovary (CHO) cells. Glofitamab-gxbm has an approximate molecular weight of 197 kDa. COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution supplied in single-dose vials for intravenous infusion. COLUMVI is supplied in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials at a concentration of 1 mg/mL. Each mL of solution contains 1 mg glofitamab-gxbm, histidine (0.63 mg), histidine hydrochloride monohydrate (3.34 mg), methionine (1.49 mg), polysorbate 20 (0.5 mg), sucrose (82.15 mg), and Water for Injection, USP, at pH 5.5.</Description>
</NDC>
<NDC>
<NDCCode>50242-127-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50242-0127-01</NDC11Code>
<ProductNDC>50242-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Columvi</ProprietaryName>
<NonProprietaryName>Glofitamab</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761309</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>GLOFITAMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager. It is a recombinant humanized anti-CD20 anti-CD3ɛ bispecific immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese hamster ovary (CHO) cells. Glofitamab-gxbm has an approximate molecular weight of 197 kDa. COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution supplied in single-dose vials for intravenous infusion. COLUMVI is supplied in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials at a concentration of 1 mg/mL. Each mL of solution contains 1 mg glofitamab-gxbm, histidine (0.63 mg), histidine hydrochloride monohydrate (3.34 mg), methionine (1.49 mg), polysorbate 20 (0.5 mg), sucrose (82.15 mg), and Water for Injection, USP, at pH 5.5.</Description>
</NDC>
<NDC>
<NDCCode>55150-197-20</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0197-20</NDC11Code>
<ProductNDC>55150-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20160915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205612</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride, USP is chemically described as S-(-)-1-propyl-2’,6’-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. ' C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>60687-661-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (60687-661-01) / 1 TABLET in 1 BLISTER PACK (60687-661-11) </PackageDescription>
<NDC11Code>60687-0661-01</NDC11Code>
<ProductNDC>60687-661</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074260</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths: 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>60687-836-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (60687-836-01) / 1 TABLET in 1 BLISTER PACK (60687-836-11) </PackageDescription>
<NDC11Code>60687-0836-01</NDC11Code>
<ProductNDC>60687-836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074260</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths: 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>67046-1689-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-1689-3) </PackageDescription>
<NDC11Code>67046-1689-03</NDC11Code>
<ProductNDC>67046-1689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216537</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3N hydrochloric acid, slightly soluble in water and methanol, practically insoluble in alcohol, acetone, ether and chloroform, with a molecular weight of 244.3. It is designated chemically as (—)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3N hydrochloric acid, insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (—)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa is supplied as tablets for oral administration in three strengths. Carbidopa and levodopa tablets USP, 25 mg/100 mg containing 25 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets USP, 10 mg/100 mg containing 10 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets USP, 25 mg/250 mg containing 25 mg of carbidopa USP and 250 mg of levodopa USP. Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize). Carbidopa and levodopa tablets USP, 10 mg/100 mg and 25 mg/250 mg also contain FD&C Blue No.2 Aluminum Lake. Carbidopa and levodopa tablets USP, 25 mg/100 mg also contain D&C Yellow No.10. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70710-2139-1</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-2139-1) </PackageDescription>
<NDC11Code>70710-2139-01</NDC11Code>
<ProductNDC>70710-2139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA203312</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>23.75; 95</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release capsules are indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4 H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>70710-2140-1</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-2140-1) </PackageDescription>
<NDC11Code>70710-2140-01</NDC11Code>
<ProductNDC>70710-2140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA203312</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>36.25; 145</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release capsules are indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4 H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>70710-2141-1</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-2141-1) </PackageDescription>
<NDC11Code>70710-2141-01</NDC11Code>
<ProductNDC>70710-2141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA203312</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>48.75; 195</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release capsules are indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4 H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>70710-2142-1</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-2142-1) </PackageDescription>
<NDC11Code>70710-2142-01</NDC11Code>
<ProductNDC>70710-2142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA203312</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>61.25; 245</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release capsules are indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4 H2O and its structural formula is. Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>72888-155-00</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-00) </PackageDescription>
<NDC11Code>72888-0155-00</NDC11Code>
<ProductNDC>72888-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217482</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release tablets, USP are extended-release oral dosage form and are combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-α-hydrazino- α -methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L- α -amino- β -(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide. Carbidopa and levodopa extended-release tablets, USP 25 mg/100 mg and 50 mg/ 200 mg also contain FD&C red 40 Alu lake and FD&C blue 2 Alu lake. The 25 mg/100 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ50” on one side and plain on other. The 50 mg/200 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ51” on one side and plain on other. The carbidopa and levodopa extended-release tablets are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablets 25 mg/100 mg are available to facilitate titration when 100 mg steps are required. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72888-155-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-01) </PackageDescription>
<NDC11Code>72888-0155-01</NDC11Code>
<ProductNDC>72888-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217482</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release tablets, USP are extended-release oral dosage form and are combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-α-hydrazino- α -methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L- α -amino- β -(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide. Carbidopa and levodopa extended-release tablets, USP 25 mg/100 mg and 50 mg/ 200 mg also contain FD&C red 40 Alu lake and FD&C blue 2 Alu lake. The 25 mg/100 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ50” on one side and plain on other. The 50 mg/200 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ51” on one side and plain on other. The carbidopa and levodopa extended-release tablets are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablets 25 mg/100 mg are available to facilitate titration when 100 mg steps are required. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
</NDCList>