{
"NDC": [
{
"NDCCode": "55648-174-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-174-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55648-0174-04",
"ProductNDC": "55648-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "55648-174-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55648-174-01)",
"NDC11Code": "55648-0174-01",
"ProductNDC": "55648-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "55648-174-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (55648-174-02)",
"NDC11Code": "55648-0174-02",
"ProductNDC": "55648-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "55648-174-03",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55648-174-03)",
"NDC11Code": "55648-0174-03",
"ProductNDC": "55648-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "43063-174-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-174-04) ",
"NDC11Code": "43063-0174-04",
"ProductNDC": "43063-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074761",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130531",
"SamplePackage": "N"
},
{
"NDCCode": "51013-174-04",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51013-174-04) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0174-04",
"ProductNDC": "51013-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Severe Cold And Flu Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160613",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160613",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms:. nasal congestion. sinus congestion & pressure. cough due to minor throat & bronchial irritation. minor aches & pains. headache. fever. sore throat."
},
{
"NDCCode": "59735-174-04",
"PackageDescription": "1 TUBE in 1 CARTON (59735-174-04) / 30 mL in 1 TUBE (59735-174-03) ",
"NDC11Code": "59735-0174-04",
"ProductNDC": "59735-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Your Name Mineral Sheertint Broad Spectrum Spf 20- Honey Glow",
"NonProprietaryName": "Your Name Mineral Sheer Tint",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "PML NYC, LLC",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "5; 5",
"StrengthUnit": "g/30mL; g/30mL",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110201",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "61924-174-04",
"PackageDescription": "106 g in 1 TUBE (61924-174-04) ",
"NDC11Code": "61924-0174-04",
"ProductNDC": "61924-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacerin",
"NonProprietaryName": "Skin Protectant",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161017",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "DermaRite Industries, LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "33",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20161017",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve dry, chapped, or cracked skin. Helps protect skin from the drying effects of wind and cold weather."
},
{
"NDCCode": "63545-174-04",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (63545-174-04) ",
"NDC11Code": "63545-0174-04",
"ProductNDC": "63545-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arsenicum Album",
"NonProprietaryName": "Arsenicum Album",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210323",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2021-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210323",
"SamplePackage": "N"
},
{
"NDCCode": "64220-174-04",
"PackageDescription": "50 kg in 1 CANISTER (64220-174-04) ",
"NDC11Code": "64220-0174-04",
"ProductNDC": "64220-174",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Paroxetine Mesylate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131108",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "PAROXETINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-08-21",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20-AUG-24"
},
{
"NDCCode": "64679-174-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-174-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0174-04",
"ProductNDC": "64679-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2."
},
{
"NDCCode": "70436-174-04",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-174-04) ",
"NDC11Code": "70436-0174-04",
"ProductNDC": "70436-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trospium Chloride",
"NonProprietaryName": "Trospium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214760",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "TROSPIUM CHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210621",
"SamplePackage": "N",
"IndicationAndUsage": "Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25H 30ClNO 3and its molecular weight is 427.97. The structural formula of trospium chloride is represented below:. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: ethylcellulose, FD&C Yellow 6, gelatin, hypromellose, methacrylic acid, methyl acrylate, methyl methacrylate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, and triethyl citrate. The imprinting ink have the following ingredients: ferrosoferric oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "83589-174-04",
"PackageDescription": "5 g in 1 TUBE (83589-174-04) ",
"NDC11Code": "83589-0174-04",
"ProductNDC": "83589-174",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Selank Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260304",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
"SubstanceName": "SELANK",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "04-MAR-26"
},
{
"NDCCode": "55648-006-04",
"PackageDescription": "1 kg in 1 CONTAINER (55648-006-04)",
"NDC11Code": "55648-0006-04",
"ProductNDC": "55648-006",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dextromethorphan Hydrobromide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19960418",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "WOCKHARDT LIMITED",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55648-105-04",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-105-04)",
"NDC11Code": "55648-0105-04",
"ProductNDC": "55648-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "(sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201331",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, glyceryl behenate, hydroxy propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2."
},
{
"NDCCode": "55648-107-04",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-107-04)",
"NDC11Code": "55648-0107-04",
"ProductNDC": "55648-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "(sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201331",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, glyceryl behenate, hydroxy propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2."
},
{
"NDCCode": "55648-152-04",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55648-152-04)",
"NDC11Code": "55648-0152-04",
"ProductNDC": "55648-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090216",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1). ● Cold Sores (Herpes Labialis). ● Genital Herpes. ● Treatment in immunocompetent patients (initial or recurrent episode). ● Suppression in immunocompetent or HIV-infected patients. ● Reduction of transmission. ● Herpes Zoster. Pediatric Patients (1.2). ● Cold Sores (Herpes Labialis). ● Chickenpox. Limitations of Use (1.3). ● The efficacy and safety of valacyclovir hydrochloride tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir hydrochloride tablets are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "55648-153-04",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55648-153-04)",
"NDC11Code": "55648-0153-04",
"ProductNDC": "55648-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090216",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1). ● Cold Sores (Herpes Labialis). ● Genital Herpes. ● Treatment in immunocompetent patients (initial or recurrent episode). ● Suppression in immunocompetent or HIV-infected patients. ● Reduction of transmission. ● Herpes Zoster. Pediatric Patients (1.2). ● Cold Sores (Herpes Labialis). ● Chickenpox. Limitations of Use (1.3). ● The efficacy and safety of valacyclovir hydrochloride tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir hydrochloride tablets are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "55648-154-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-154-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55648-0154-04",
"ProductNDC": "55648-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "55648-155-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-155-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55648-0155-04",
"ProductNDC": "55648-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "55648-171-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-171-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55648-0171-04",
"ProductNDC": "55648-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "55648-172-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-172-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55648-0172-04",
"ProductNDC": "55648-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "55648-175-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-175-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55648-0175-04",
"ProductNDC": "55648-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "55648-177-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-177-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55648-0177-04",
"ProductNDC": "55648-177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2."
},
{
"NDCCode": "55648-215-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-215-04) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55648-0215-04",
"ProductNDC": "55648-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium And Misoprostol",
"NonProprietaryName": "Diclofenac Sodium And Misoprostol",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201948",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "50; .2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55648-217-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-217-04) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55648-0217-04",
"ProductNDC": "55648-217",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium And Misoprostol",
"NonProprietaryName": "Diclofenac Sodium And Misoprostol",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201948",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "75; .2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55648-271-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-271-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55648-0271-04",
"ProductNDC": "55648-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202498",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: : 1 adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. (1.1), 2 Limitation of use: Safety and effectiveness in patients less than 13 years of age have not been established. (1.3).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet) and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
},
{
"NDCCode": "55648-272-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-272-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55648-0272-04",
"ProductNDC": "55648-272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202498",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: : 1 adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. (1.1), 2 Limitation of use: Safety and effectiveness in patients less than 13 years of age have not been established. (1.3).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet) and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
},
{
"NDCCode": "55648-273-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-273-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55648-0273-04",
"ProductNDC": "55648-273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202498",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: : 1 adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. (1.1), 2 Limitation of use: Safety and effectiveness in patients less than 13 years of age have not been established. (1.3).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet) and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
},
{
"NDCCode": "55648-275-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-275-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55648-0275-04",
"ProductNDC": "55648-275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202498",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: : 1 adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. (1.1), 2 Limitation of use: Safety and effectiveness in patients less than 13 years of age have not been established. (1.3).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet) and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
}
]
}
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Wockhardt Limited</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
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<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Wockhardt Limited</LabelerName>
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<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
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<NDCCode>55648-174-02</NDCCode>
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<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
</NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Wockhardt Limited</LabelerName>
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<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43063-174-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-174-04) </PackageDescription>
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<ProductNDC>43063-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074761</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51013-174-04</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51013-174-04) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51013-0174-04</NDC11Code>
<ProductNDC>51013-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Severe Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160613</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms:. nasal congestion. sinus congestion & pressure. cough due to minor throat & bronchial irritation. minor aches & pains. headache. fever. sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59735-174-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59735-174-04) / 30 mL in 1 TUBE (59735-174-03) </PackageDescription>
<NDC11Code>59735-0174-04</NDC11Code>
<ProductNDC>59735-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Your Name Mineral Sheertint Broad Spectrum Spf 20- Honey Glow</ProprietaryName>
<NonProprietaryName>Your Name Mineral Sheer Tint</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>PML NYC, LLC</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>5; 5</StrengthNumber>
<StrengthUnit>g/30mL; g/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61924-174-04</NDCCode>
<PackageDescription>106 g in 1 TUBE (61924-174-04) </PackageDescription>
<NDC11Code>61924-0174-04</NDC11Code>
<ProductNDC>61924-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacerin</ProprietaryName>
<NonProprietaryName>Skin Protectant</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161017</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>DermaRite Industries, LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>33</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects and helps relieve dry, chapped, or cracked skin. Helps protect skin from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63545-174-04</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (63545-174-04) </PackageDescription>
<NDC11Code>63545-0174-04</NDC11Code>
<ProductNDC>63545-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arsenicum Album</ProprietaryName>
<NonProprietaryName>Arsenicum Album</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210323</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64220-174-04</NDCCode>
<PackageDescription>50 kg in 1 CANISTER (64220-174-04) </PackageDescription>
<NDC11Code>64220-0174-04</NDC11Code>
<ProductNDC>64220-174</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Paroxetine Mesylate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131108</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PAROXETINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-08-21</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-AUG-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64679-174-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-174-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0174-04</NDC11Code>
<ProductNDC>64679-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70436-174-04</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-174-04) </PackageDescription>
<NDC11Code>70436-0174-04</NDC11Code>
<ProductNDC>70436-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trospium Chloride</ProprietaryName>
<NonProprietaryName>Trospium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214760</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TROSPIUM CHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25H 30ClNO 3and its molecular weight is 427.97. The structural formula of trospium chloride is represented below:. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: ethylcellulose, FD&C Yellow 6, gelatin, hypromellose, methacrylic acid, methyl acrylate, methyl methacrylate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, and triethyl citrate. The imprinting ink have the following ingredients: ferrosoferric oxide, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>83589-174-04</NDCCode>
<PackageDescription>5 g in 1 TUBE (83589-174-04) </PackageDescription>
<NDC11Code>83589-0174-04</NDC11Code>
<ProductNDC>83589-174</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Selank Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260304</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SELANK</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-MAR-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>55648-006-04</NDCCode>
<PackageDescription>1 kg in 1 CONTAINER (55648-006-04)</PackageDescription>
<NDC11Code>55648-0006-04</NDC11Code>
<ProductNDC>55648-006</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19960418</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>WOCKHARDT LIMITED</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55648-105-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-105-04)</PackageDescription>
<NDC11Code>55648-0105-04</NDC11Code>
<ProductNDC>55648-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201331</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, glyceryl behenate, hydroxy propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55648-107-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-107-04)</PackageDescription>
<NDC11Code>55648-0107-04</NDC11Code>
<ProductNDC>55648-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201331</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, glyceryl behenate, hydroxy propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55648-152-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55648-152-04)</PackageDescription>
<NDC11Code>55648-0152-04</NDC11Code>
<ProductNDC>55648-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090216</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1). ● Cold Sores (Herpes Labialis). ● Genital Herpes. ● Treatment in immunocompetent patients (initial or recurrent episode). ● Suppression in immunocompetent or HIV-infected patients. ● Reduction of transmission. ● Herpes Zoster. Pediatric Patients (1.2). ● Cold Sores (Herpes Labialis). ● Chickenpox. Limitations of Use (1.3). ● The efficacy and safety of valacyclovir hydrochloride tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir hydrochloride tablets are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>55648-153-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55648-153-04)</PackageDescription>
<NDC11Code>55648-0153-04</NDC11Code>
<ProductNDC>55648-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090216</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1). ● Cold Sores (Herpes Labialis). ● Genital Herpes. ● Treatment in immunocompetent patients (initial or recurrent episode). ● Suppression in immunocompetent or HIV-infected patients. ● Reduction of transmission. ● Herpes Zoster. Pediatric Patients (1.2). ● Cold Sores (Herpes Labialis). ● Chickenpox. Limitations of Use (1.3). ● The efficacy and safety of valacyclovir hydrochloride tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir hydrochloride tablets are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>55648-154-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-154-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0154-04</NDC11Code>
<ProductNDC>55648-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55648-155-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-155-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0155-04</NDC11Code>
<ProductNDC>55648-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55648-171-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-171-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0171-04</NDC11Code>
<ProductNDC>55648-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55648-172-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-172-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0172-04</NDC11Code>
<ProductNDC>55648-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55648-175-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-175-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0175-04</NDC11Code>
<ProductNDC>55648-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55648-177-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-177-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0177-04</NDC11Code>
<ProductNDC>55648-177</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg meet, USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55648-215-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-215-04) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0215-04</NDC11Code>
<ProductNDC>55648-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201948</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; .2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55648-217-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-217-04) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0217-04</NDC11Code>
<ProductNDC>55648-217</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201948</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>75; .2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55648-271-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-271-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0271-04</NDC11Code>
<ProductNDC>55648-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202498</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: : 1 adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. (1.1), 2 Limitation of use: Safety and effectiveness in patients less than 13 years of age have not been established. (1.3).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet) and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
</NDC>
<NDC>
<NDCCode>55648-272-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-272-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0272-04</NDC11Code>
<ProductNDC>55648-272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202498</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: : 1 adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. (1.1), 2 Limitation of use: Safety and effectiveness in patients less than 13 years of age have not been established. (1.3).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet) and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
</NDC>
<NDC>
<NDCCode>55648-273-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-273-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0273-04</NDC11Code>
<ProductNDC>55648-273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202498</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: : 1 adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. (1.1), 2 Limitation of use: Safety and effectiveness in patients less than 13 years of age have not been established. (1.3).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet) and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
</NDC>
<NDC>
<NDCCode>55648-275-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-275-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0275-04</NDC11Code>
<ProductNDC>55648-275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202498</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: : 1 adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. (1.1), 2 Limitation of use: Safety and effectiveness in patients less than 13 years of age have not been established. (1.3).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine Extended-Release Tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet) and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
</NDC>
</NDCList>