{
"NDC": [
{
"NDCCode": "50580-244-80",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-244-80) > 80 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0244-80",
"ProductNDC": "50580-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part338",
"LabelerName": "McNeil Consumer Healthcare Div McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "50580-244-03",
"PackageDescription": "2 TABLET, COATED in 1 POUCH (50580-244-03)",
"NDC11Code": "50580-0244-03",
"ProductNDC": "50580-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part338",
"LabelerName": "McNeil Consumer Healthcare Div McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "50580-244-08",
"PackageDescription": "12 VIAL, PLASTIC in 1 CARTON (50580-244-08) > 8 TABLET, COATED in 1 VIAL, PLASTIC",
"NDC11Code": "50580-0244-08",
"ProductNDC": "50580-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part338",
"LabelerName": "McNeil Consumer Healthcare Div McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "50580-244-20",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-244-20) > 20 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0244-20",
"ProductNDC": "50580-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part338",
"LabelerName": "McNeil Consumer Healthcare Div McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "50580-244-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-244-40) > 40 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0244-40",
"ProductNDC": "50580-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part338",
"LabelerName": "McNeil Consumer Healthcare Div McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "43744-244-80",
"PackageDescription": "20000 g in 1 DRUM (43744-244-80)",
"NDC11Code": "43744-0244-80",
"ProductNDC": "43744-244",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dantrolene Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20100720",
"EndMarketingDate": "20130630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "DANTROLENE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130630"
},
{
"NDCCode": "80057-001-05",
"PackageDescription": "80 POUCH in 1 PACKAGE (80057-001-05) / 244.94 g in 1 POUCH",
"NDC11Code": "80057-0001-05",
"ProductNDC": "80057-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing Wipes",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200820",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Bright Commodity Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200820",
"SamplePackage": "N",
"IndicationAndUsage": "Sanitizes Hands."
},
{
"NDCCode": "80057-002-05",
"PackageDescription": "80 POUCH in 1 PACKAGE (80057-002-05) / 244.94 g in 1 POUCH",
"NDC11Code": "80057-0002-05",
"ProductNDC": "80057-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Line Alcohol Wipes",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200905",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Bright Commodity Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200905",
"SamplePackage": "N",
"IndicationAndUsage": "Topical antiseptic."
},
{
"NDCCode": "85766-244-80",
"PackageDescription": "1 TUBE in 1 CARTON (85766-244-80) / 80 g in 1 TUBE",
"NDC11Code": "85766-0244-80",
"ProductNDC": "85766-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209535",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260713",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "50580-120-80",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-120-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0120-80",
"ProductNDC": "50580-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motrin Ib Migraine",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078682",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210118",
"SamplePackage": "N",
"IndicationAndUsage": "treats migraine."
},
{
"NDCCode": "50580-208-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (50580-208-08) / 80 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "50580-0208-08",
"ProductNDC": "50580-208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motrin Dual Action With Tylenol",
"NonProprietaryName": "Acetaminophen And Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214836",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "IBUPROFEN; ACETAMINOPHEN",
"StrengthNumber": "125; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230320",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves minor aches and pains due to. ■ headache. ■ toothache. ■ backache. ■ menstrual cramps. ■ muscular aches. ■ minor pain of arthritis."
},
{
"NDCCode": "50580-208-16",
"PackageDescription": "2 CARTON in 1 CARTON (50580-208-16) / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "50580-0208-16",
"ProductNDC": "50580-208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motrin Dual Action With Tylenol",
"NonProprietaryName": "Acetaminophen And Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214836",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "IBUPROFEN; ACETAMINOPHEN",
"StrengthNumber": "125; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves minor aches and pains due to. ■ headache. ■ toothache. ■ backache. ■ menstrual cramps. ■ muscular aches. ■ minor pain of arthritis."
},
{
"NDCCode": "50580-409-80",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-409-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0409-80",
"ProductNDC": "50580-409",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motrin Ib",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20150126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078682",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150126",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headache. toothache. backache. menstrual cramps. the common cold. muscular aches. minor pain of arthritis. temporarily reduces fever."
},
{
"NDCCode": "50580-501-80",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-501-80) ",
"NDC11Code": "50580-0501-80",
"ProductNDC": "50580-501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol",
"ProprietaryNameSuffix": "Regular Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19990201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "50580-563-80",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0563-80",
"ProductNDC": "50580-563",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motrin",
"ProprietaryNameSuffix": "Pm",
"NonProprietaryName": "Ibuprofen And Diphenhydramine Citrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079113",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "IBUPROFEN; DIPHENHYDRAMINE CITRATE",
"StrengthNumber": "200; 38",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100111",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness when associated with minor aches and pains. helps you fall asleep and stay asleep."
},
{
"NDCCode": "50580-518-30",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-518-30) > 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0518-30",
"ProductNDC": "50580-518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Tylenol",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20040801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "McNeil Consumer Healthcare Div. McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-06-17"
},
{
"NDCCode": "69968-0799-9",
"PackageDescription": "1 KIT in 1 PACKAGE (69968-0799-9) * 1 TUBE in 1 CARTON (69968-0055-2) / 14.2 g in 1 TUBE * 1 CLOTH in 1 PACKET * 2 TABLET, FILM COATED in 1 POUCH (50580-449-08) ",
"NDC11Code": "69968-0799-09",
"ProductNDC": "69968-0799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Johnson And Johnson First Aid Travel Ready",
"ProprietaryNameSuffix": "80 Ct",
"NonProprietaryName": "Acetaminophen, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20220131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Kenvue Brands LLC",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220131",
"SamplePackage": "N"
},
{
"NDCCode": "0143-9606-01",
"PackageDescription": "1 VIAL in 1 CARTON (0143-9606-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00143-9606-01",
"ProductNDC": "0143-9606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azacitidine",
"NonProprietaryName": "Azacitidine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20200608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209337",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "AZACITIDINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200608",
"SamplePackage": "N",
"IndicationAndUsage": "Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).",
"Description": "Azacitidine for Injection contains azacitidine, which is a pyrimidine nucleoside analog of cytidine. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244. Azacitidine is a white to off-white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of Azacitidine for Injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder."
},
{
"NDCCode": "0574-0792-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0792-01) ",
"NDC11Code": "00574-0792-01",
"ProductNDC": "0574-0792",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pilocarpine Hydrchloride",
"NonProprietaryName": "Pilocarpine Hydrchloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200824",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076746",
"LabelerName": "Padagis US LLC",
"SubstanceName": "PILOCARPINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200824",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Pilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.",
"Description": "Pilocarpine hydrochloride tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder, which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2 (3H)- Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl) methyl] monohydrochloride, has a molecular weight of 244.72. Each pilocarpine hydrochloride tablet for oral administration contains 5 mg of pilocarpine hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid and titanium dioxide."
},
{
"NDCCode": "0781-3253-94",
"PackageDescription": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3253-94) ",
"NDC11Code": "00781-3253-94",
"ProductNDC": "0781-3253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azacitidine",
"NonProprietaryName": "Azacitidine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20130916",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050794",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AZACITIDINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130916",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: 1 Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1.1), 2 Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). (1.2).",
"Description": "Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244. Azacitidine for injection is a white to off-white solid. Azacitidine for injection was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder."
},
{
"NDCCode": "0781-5613-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5613-01) ",
"NDC11Code": "00781-5613-01",
"ProductNDC": "0781-5613",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140618",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021485",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "12.5; 50; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140618",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide."
},
{
"NDCCode": "0781-5625-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5625-01) ",
"NDC11Code": "00781-5625-01",
"ProductNDC": "0781-5625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140618",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021485",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "18.75; 75; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140618",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide."
},
{
"NDCCode": "0781-5637-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5637-01) ",
"NDC11Code": "00781-5637-01",
"ProductNDC": "0781-5637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140618",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021485",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "25; 100; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140618",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide."
},
{
"NDCCode": "0781-5641-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5641-01) ",
"NDC11Code": "00781-5641-01",
"ProductNDC": "0781-5641",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140618",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021485",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "31.25; 125; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140618",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide."
},
{
"NDCCode": "0781-5654-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5654-01) ",
"NDC11Code": "00781-5654-01",
"ProductNDC": "0781-5654",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140618",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021485",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "37.5; 150; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140618",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide."
},
{
"NDCCode": "0781-5669-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5669-01) ",
"NDC11Code": "00781-5669-01",
"ProductNDC": "0781-5669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140618",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021485",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "50; 200; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140618",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide."
},
{
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"PackageDescription": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-9253-94) ",
"NDC11Code": "00781-9253-94",
"ProductNDC": "0781-9253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azacitidine",
"NonProprietaryName": "Azacitidine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20140327",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050794",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AZACITIDINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: 1 Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1.1), 2 Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). (1.2).",
"Description": "Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244. Azacitidine for injection is a white to off-white solid. Azacitidine for injection was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder."
},
{
"NDCCode": "16571-689-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16571-689-01) ",
"NDC11Code": "16571-0689-01",
"ProductNDC": "16571-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213212",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "12.5; 50; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210805",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.",
"Description": "Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, microcrystalline cellulose, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide."
},
{
"NDCCode": "16571-690-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16571-690-01) ",
"NDC11Code": "16571-0690-01",
"ProductNDC": "16571-690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213212",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "18.75; 75; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210805",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.",
"Description": "Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, microcrystalline cellulose, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide."
},
{
"NDCCode": "16571-691-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16571-691-01) ",
"NDC11Code": "16571-0691-01",
"ProductNDC": "16571-691",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213212",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "25; 100; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210805",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.",
"Description": "Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, microcrystalline cellulose, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide."
}
]
}
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<SubstanceName>DANTROLENE SODIUM</SubstanceName>
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</NDC>
<NDC>
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<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Bright Commodity Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sanitizes Hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80057-002-05</NDCCode>
<PackageDescription>80 POUCH in 1 PACKAGE (80057-002-05) / 244.94 g in 1 POUCH</PackageDescription>
<NDC11Code>80057-0002-05</NDC11Code>
<ProductNDC>80057-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Line Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200905</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Bright Commodity Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical antiseptic.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85766-244-80</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (85766-244-80) / 80 g in 1 TUBE</PackageDescription>
<NDC11Code>85766-0244-80</NDC11Code>
<ProductNDC>85766-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209535</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>50580-120-80</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-120-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0120-80</NDC11Code>
<ProductNDC>50580-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motrin Ib Migraine</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078682</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats migraine.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-208-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50580-208-08) / 80 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>50580-0208-08</NDC11Code>
<ProductNDC>50580-208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motrin Dual Action With Tylenol</ProprietaryName>
<NonProprietaryName>Acetaminophen And Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214836</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>IBUPROFEN; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>125; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves minor aches and pains due to. ■ headache. ■ toothache. ■ backache. ■ menstrual cramps. ■ muscular aches. ■ minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-208-16</NDCCode>
<PackageDescription>2 CARTON in 1 CARTON (50580-208-16) / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>50580-0208-16</NDC11Code>
<ProductNDC>50580-208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motrin Dual Action With Tylenol</ProprietaryName>
<NonProprietaryName>Acetaminophen And Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214836</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>IBUPROFEN; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>125; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves minor aches and pains due to. ■ headache. ■ toothache. ■ backache. ■ menstrual cramps. ■ muscular aches. ■ minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-409-80</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-409-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0409-80</NDC11Code>
<ProductNDC>50580-409</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motrin Ib</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078682</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. headache. toothache. backache. menstrual cramps. the common cold. muscular aches. minor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-501-80</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-501-80) </PackageDescription>
<NDC11Code>50580-0501-80</NDC11Code>
<ProductNDC>50580-501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol</ProprietaryName>
<ProprietaryNameSuffix>Regular Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50580-563-80</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0563-80</NDC11Code>
<ProductNDC>50580-563</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motrin</ProprietaryName>
<ProprietaryNameSuffix>Pm</ProprietaryNameSuffix>
<NonProprietaryName>Ibuprofen And Diphenhydramine Citrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079113</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>IBUPROFEN; DIPHENHYDRAMINE CITRATE</SubstanceName>
<StrengthNumber>200; 38</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional sleeplessness when associated with minor aches and pains. helps you fall asleep and stay asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-518-30</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-518-30) > 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0518-30</NDC11Code>
<ProductNDC>50580-518</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Tylenol</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>McNeil Consumer Healthcare Div. McNeil-PPC, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-06-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>69968-0799-9</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (69968-0799-9) * 1 TUBE in 1 CARTON (69968-0055-2) / 14.2 g in 1 TUBE * 1 CLOTH in 1 PACKET * 2 TABLET, FILM COATED in 1 POUCH (50580-449-08) </PackageDescription>
<NDC11Code>69968-0799-09</NDC11Code>
<ProductNDC>69968-0799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Johnson And Johnson First Aid Travel Ready</ProprietaryName>
<ProprietaryNameSuffix>80 Ct</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220131</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0143-9606-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0143-9606-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>00143-9606-01</NDC11Code>
<ProductNDC>0143-9606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azacitidine</ProprietaryName>
<NonProprietaryName>Azacitidine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209337</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AZACITIDINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).</IndicationAndUsage>
<Description>Azacitidine for Injection contains azacitidine, which is a pyrimidine nucleoside analog of cytidine. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244. Azacitidine is a white to off-white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of Azacitidine for Injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.</Description>
</NDC>
<NDC>
<NDCCode>0574-0792-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0792-01) </PackageDescription>
<NDC11Code>00574-0792-01</NDC11Code>
<ProductNDC>0574-0792</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pilocarpine Hydrchloride</ProprietaryName>
<NonProprietaryName>Pilocarpine Hydrchloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200824</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076746</ApplicationNumber>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200824</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.</IndicationAndUsage>
<Description>Pilocarpine hydrochloride tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder, which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2 (3H)- Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl) methyl] monohydrochloride, has a molecular weight of 244.72. Each pilocarpine hydrochloride tablet for oral administration contains 5 mg of pilocarpine hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0781-3253-94</NDCCode>
<PackageDescription>1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3253-94) </PackageDescription>
<NDC11Code>00781-3253-94</NDC11Code>
<ProductNDC>0781-3253</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azacitidine</ProprietaryName>
<NonProprietaryName>Azacitidine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130916</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050794</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AZACITIDINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130916</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: 1 Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1.1), 2 Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). (1.2).</IndicationAndUsage>
<Description>Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244. Azacitidine for injection is a white to off-white solid. Azacitidine for injection was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.</Description>
</NDC>
<NDC>
<NDCCode>0781-5613-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0781-5613-01) </PackageDescription>
<NDC11Code>00781-5613-01</NDC11Code>
<ProductNDC>0781-5613</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa, Levodopa, And Entacapone</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa, And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140618</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
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<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide.</Description>
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<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide.</Description>
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<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide.</Description>
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<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide.</Description>
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<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide.</Description>
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<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide.</Description>
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<PackageDescription>1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-9253-94) </PackageDescription>
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<ProductNDC>0781-9253</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azacitidine</ProprietaryName>
<NonProprietaryName>Azacitidine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140327</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050794</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AZACITIDINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140327</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: 1 Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1.1), 2 Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). (1.2).</IndicationAndUsage>
<Description>Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244. Azacitidine for injection is a white to off-white solid. Azacitidine for injection was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.</Description>
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<NDC>
<NDCCode>16571-689-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16571-689-01) </PackageDescription>
<NDC11Code>16571-0689-01</NDC11Code>
<ProductNDC>16571-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213212</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
<StrengthNumber>12.5; 50; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, microcrystalline cellulose, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>16571-690-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16571-690-01) </PackageDescription>
<NDC11Code>16571-0690-01</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213212</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
<StrengthNumber>18.75; 75; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, microcrystalline cellulose, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>16571-691-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16571-691-01) </PackageDescription>
<NDC11Code>16571-0691-01</NDC11Code>
<ProductNDC>16571-691</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213212</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
<StrengthNumber>25; 100; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. 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 C10H14N2O4H2O, 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 C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone tablets are supplied as tablets in 6 strengths. Carbidopa, levodopa and entacapone tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Carbidopa, levodopa and entacapone tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, microcrystalline cellulose, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide.</Description>
</NDC>
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