{
"NDC": [
{
"NDCCode": "62037-777-14",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (62037-777-14) > 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "62037-0777-14",
"ProductNDC": "62037-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"EndMarketingDate": "20150731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065145",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-08-07"
},
{
"NDCCode": "62037-777-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-777-05)",
"NDC11Code": "62037-0777-05",
"ProductNDC": "62037-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"EndMarketingDate": "20150731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065145",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-08-07"
},
{
"NDCCode": "62037-777-10",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-777-10)",
"NDC11Code": "62037-0777-10",
"ProductNDC": "62037-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"EndMarketingDate": "20150731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065145",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-08-07"
},
{
"NDCCode": "62037-777-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-777-60)",
"NDC11Code": "62037-0777-60",
"ProductNDC": "62037-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"EndMarketingDate": "20150731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065145",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-08-07"
},
{
"NDCCode": "23155-777-72",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (23155-777-72) ",
"NDC11Code": "23155-0777-72",
"ProductNDC": "23155-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078879",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N"
},
{
"NDCCode": "65841-777-14",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-14) ",
"NDC11Code": "65841-0777-14",
"ProductNDC": "65841-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091134",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140215",
"SamplePackage": "N"
},
{
"NDCCode": "71205-777-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (71205-777-14) ",
"NDC11Code": "71205-0777-14",
"ProductNDC": "71205-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isentress",
"NonProprietaryName": "Raltegravir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071012",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022145",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "RALTEGRAVIR POTASSIUM",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230315",
"SamplePackage": "N",
"IndicationAndUsage": "Adult Patients. ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (1). Pediatric Patients. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg (1). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg (1).",
"Description": "ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl) methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt. The empirical formula is C20H20FKN6O5 and the molecular weight is 482.51. The structural formula is. Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol. Each 400 mg film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir (as potassium salt), equivalent to 400 mg of raltegravir free phenol and the following inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide. Each 600 mg film-coated tablet of ISENTRESS HD for oral administration contains 651.6 mg of raltegravir (as potassium salt), equivalent to 600 mg of raltegravir free phenol and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, magnesium stearate, microcrystalline cellulose. The film coating contains the following inactive ingredients: ferrosoferric oxide, hypromellose 2910, iron oxide yellow, lactose monohydrate, triacetin and titanium dioxide. The tablet may also contain trace amount of carnauba wax. Each 100 mg chewable tablet of ISENTRESS for oral administration contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, red iron oxide, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each 25 mg chewable tablet of ISENTRESS for oral administration contains 27.16 mg of raltegravir (as potassium salt), equivalent to 25 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each packet of ISENTRESS for oral suspension 100 mg, contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, banana with other natural flavors, carboxymethylcellulose sodium, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, microcrystalline cellulose, monoammonium glycyrrhizinate, oleic acid, sorbitol, sucralose and sucrose."
},
{
"NDCCode": "16571-777-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16571-777-01) ",
"NDC11Code": "16571-0777-01",
"ProductNDC": "16571-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20061002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078008",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061002",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: : 1 Osteoarthritis (OA) (1.1) , 2 Rheumatoid Arthritis (RA) (1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam USP is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam USP. The inactive ingredients in meloxicam tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate (trisodium citrate dihydrate)."
},
{
"NDCCode": "16571-777-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-777-10) ",
"NDC11Code": "16571-0777-10",
"ProductNDC": "16571-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20061002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078008",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061002",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: : 1 Osteoarthritis (OA) (1.1) , 2 Rheumatoid Arthritis (RA) (1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam USP is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam USP. The inactive ingredients in meloxicam tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate (trisodium citrate dihydrate)."
},
{
"NDCCode": "16571-777-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-777-50) ",
"NDC11Code": "16571-0777-50",
"ProductNDC": "16571-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20061002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078008",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061002",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: : 1 Osteoarthritis (OA) (1.1) , 2 Rheumatoid Arthritis (RA) (1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam USP is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam USP. The inactive ingredients in meloxicam tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate (trisodium citrate dihydrate)."
},
{
"NDCCode": "21695-777-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-777-30)",
"NDC11Code": "21695-0777-30",
"ProductNDC": "21695-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075155",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane."
},
{
"NDCCode": "42291-777-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42291-777-30) ",
"NDC11Code": "42291-0777-30",
"ProductNDC": "42291-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209745",
"LabelerName": "AvKARE",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221004",
"SamplePackage": "N",
"IndicationAndUsage": "Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)] . Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2 R)-2-({2-[2-(2,2,2- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1 H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4 with a molecular weight of 495.53. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin capsules, 4 mg and 8 mg for oral administration contains 4 mg or 8 mg silodosin respectively and inactive ingredients: gelatin, mannitol, pregelatinized starch [Botanical source: corn (maize)], sodium lauryl sulphate, sodium stearyl fumarate and titanium dioxide. Each capsule of 4 mg and 8 mg are imprinted with gold pharmaceutical ink or green pharmaceutical ink respectively and contains: FD & C blue #2 aluminum lake (green pharmaceutical ink), butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, titanium dioxide (green pharmaceutical ink), and yellow iron oxide."
},
{
"NDCCode": "55700-777-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-777-30) ",
"NDC11Code": "55700-0777-30",
"ProductNDC": "55700-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078148",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190719",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem Tartrate Extended-Release Tablets, USP, are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see CLINICAL STUDIES (14)].",
"Description": "Zolpidem Tartrate Extended-Release Tablets, USP, contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class. Zolpidem tartrate extended-release tablets are available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Zolpidem tartrate extended-release tablets are film coated containing a hydrogel-matrix core that provides extended-release of the drug content. The 6.25 mg zolpidem tartrate extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C yellow #6/sunset yellow FCF aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, sugar, titanium dioxide and talc. The 12.5 mg zolpidem tartrate extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, sugar, titanium dioxide and triacetin. Meets USP Dissolution Test 3."
},
{
"NDCCode": "61919-777-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (61919-777-30)",
"NDC11Code": "61919-0777-30",
"ProductNDC": "61919-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090170",
"LabelerName": "Direct RX",
"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": "20171231",
"IndicationAndUsage": "1.1 Epilepsy. Adjunctive Therapy. Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age:partial seizuresprimary generalized tonic-clonic seizuresgeneralized seizures of Lennox-Gastaut syndrome. Monotherapy. Lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.2 Bipolar Disorder. Lamotrigine tablets are indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (≥18 years of age) treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established. The effectiveness of lamotrigine tablets as maintenance treatment was established in 2 placebo-controlled trials in patients with Bipolar I Disorder as defined by DSM-IV [see Clinical Studies (14.2)]. The physician who elects to prescribe lamotrigine tablets for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"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 to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:Lamotrigine tablets USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, the 200 mg tablets contain FD&C Blue No. 2 Lake."
},
{
"NDCCode": "68462-777-35",
"PackageDescription": "25 VIAL in 1 CARTON (68462-777-35) / 10 mL in 1 VIAL (68462-777-10) ",
"NDC11Code": "68462-0777-35",
"ProductNDC": "68462-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION",
"StartMarketingDate": "20251008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219883",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251008",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "73581-777-20",
"PackageDescription": "200 TABLET in 1 BOTTLE (73581-777-20) ",
"NDC11Code": "73581-0777-20",
"ProductNDC": "73581-777",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibs Labs - Anti-diarrheal",
"ProprietaryNameSuffix": "Original Prescription Strength, 2 Mg",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076497",
"LabelerName": "YYBA",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230509",
"SamplePackage": "N"
},
{
"NDCCode": "73581-777-96",
"PackageDescription": "96 TABLET in 1 BOTTLE (73581-777-96) ",
"NDC11Code": "73581-0777-96",
"ProductNDC": "73581-777",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibs Labs - Anti-diarrheal",
"ProprietaryNameSuffix": "Original Prescription Strength, 2 Mg",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076497",
"LabelerName": "YYBA",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230509",
"SamplePackage": "N"
},
{
"NDCCode": "80673-777-01",
"PackageDescription": "1 CARTON in 1 BOX (80673-777-01) / 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) / 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01) ",
"NDC11Code": "80673-0777-01",
"ProductNDC": "80673-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebanga",
"NonProprietaryName": "Ansuvimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20201221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761172",
"LabelerName": "Ridgeback Biotherapeutics, LP",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201221",
"SamplePackage": "N",
"IndicationAndUsage": "EBANGA is indicated for the treatment of infection caused by Zaire ebolavirusin adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirusinfection [see Dosage and Administration (2.2)and Clinical Studies (14)] .",
"Description": "Ansuvimab-zykl is a Zaire ebolavirus(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6."
},
{
"NDCCode": "80673-777-04",
"PackageDescription": "4 CARTON in 1 BOX (80673-777-04) / 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) / 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01) ",
"NDC11Code": "80673-0777-04",
"ProductNDC": "80673-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebanga",
"NonProprietaryName": "Ansuvimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20201221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761172",
"LabelerName": "Ridgeback Biotherapeutics, LP",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201221",
"SamplePackage": "N",
"IndicationAndUsage": "EBANGA is indicated for the treatment of infection caused by Zaire ebolavirusin adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirusinfection [see Dosage and Administration (2.2)and Clinical Studies (14)] .",
"Description": "Ansuvimab-zykl is a Zaire ebolavirus(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6."
},
{
"NDCCode": "80673-777-08",
"PackageDescription": "8 CARTON in 1 BOX (80673-777-08) / 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) / 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01) ",
"NDC11Code": "80673-0777-08",
"ProductNDC": "80673-777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebanga",
"NonProprietaryName": "Ansuvimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20201221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761172",
"LabelerName": "Ridgeback Biotherapeutics, LP",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201221",
"SamplePackage": "N",
"IndicationAndUsage": "EBANGA is indicated for the treatment of infection caused by Zaire ebolavirusin adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirusinfection [see Dosage and Administration (2.2)and Clinical Studies (14)] .",
"Description": "Ansuvimab-zykl is a Zaire ebolavirus(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6."
},
{
"NDCCode": "62037-524-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62037-524-01) ",
"NDC11Code": "62037-0524-01",
"ProductNDC": "62037-524",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Ibuprofen",
"NonProprietaryName": "Hydrocodone Bitartrate And Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040401",
"EndMarketingDate": "20190930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076604",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; IBUPROFEN",
"StrengthNumber": "7.5; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040401",
"EndMarketingDatePackage": "20190930",
"SamplePackage": "N"
},
{
"NDCCode": "62037-524-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62037-524-05) ",
"NDC11Code": "62037-0524-05",
"ProductNDC": "62037-524",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Ibuprofen",
"NonProprietaryName": "Hydrocodone Bitartrate And Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040401",
"EndMarketingDate": "20190930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076604",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; IBUPROFEN",
"StrengthNumber": "7.5; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040401",
"EndMarketingDatePackage": "20190531",
"SamplePackage": "N"
},
{
"NDCCode": "62037-559-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-559-01) ",
"NDC11Code": "62037-0559-01",
"ProductNDC": "62037-559",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080825",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077419",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080825",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release capsules USP, 8 mEq and 10 mEq are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The inactive ingredients are, ethylcellulose, FD&C Blue #1, FD&C Red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triacetin."
},
{
"NDCCode": "62037-559-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-559-05) ",
"NDC11Code": "62037-0559-05",
"ProductNDC": "62037-559",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080825",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077419",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080825",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release capsules USP, 8 mEq and 10 mEq are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The inactive ingredients are, ethylcellulose, FD&C Blue #1, FD&C Red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triacetin."
},
{
"NDCCode": "62037-559-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-559-10) ",
"NDC11Code": "62037-0559-10",
"ProductNDC": "62037-559",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077419",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20080825",
"SamplePackage": "N"
},
{
"NDCCode": "62037-560-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-560-01) ",
"NDC11Code": "62037-0560-01",
"ProductNDC": "62037-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080825",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077419",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080825",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release capsules USP, 8 mEq and 10 mEq are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The inactive ingredients are, ethylcellulose, FD&C Blue #1, FD&C Red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triacetin."
},
{
"NDCCode": "62037-560-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-560-05) ",
"NDC11Code": "62037-0560-05",
"ProductNDC": "62037-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080825",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077419",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080825",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release capsules USP, 8 mEq and 10 mEq are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The inactive ingredients are, ethylcellulose, FD&C Blue #1, FD&C Red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triacetin."
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"Description": "Potassium chloride extended-release capsules USP, 8 mEq and 10 mEq are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The inactive ingredients are, ethylcellulose, FD&C Blue #1, FD&C Red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triacetin."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release capsules USP, 8 mEq and 10 mEq are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The inactive ingredients are, ethylcellulose, FD&C Blue #1, FD&C Red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triacetin."
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{
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"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
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"LabelerName": "Watson Pharma, Inc.",
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]
}
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<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
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<ProductNDC>65841-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
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<Status>Active</Status>
<LastUpdate>2024-12-03</LastUpdate>
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<IndicationAndUsage>Adult Patients. ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (1). Pediatric Patients. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg (1). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg (1).</IndicationAndUsage>
<Description>ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl) methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt. The empirical formula is C20H20FKN6O5 and the molecular weight is 482.51. The structural formula is. Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol. Each 400 mg film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir (as potassium salt), equivalent to 400 mg of raltegravir free phenol and the following inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide. Each 600 mg film-coated tablet of ISENTRESS HD for oral administration contains 651.6 mg of raltegravir (as potassium salt), equivalent to 600 mg of raltegravir free phenol and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, magnesium stearate, microcrystalline cellulose. The film coating contains the following inactive ingredients: ferrosoferric oxide, hypromellose 2910, iron oxide yellow, lactose monohydrate, triacetin and titanium dioxide. The tablet may also contain trace amount of carnauba wax. Each 100 mg chewable tablet of ISENTRESS for oral administration contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, red iron oxide, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each 25 mg chewable tablet of ISENTRESS for oral administration contains 27.16 mg of raltegravir (as potassium salt), equivalent to 25 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each packet of ISENTRESS for oral suspension 100 mg, contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, banana with other natural flavors, carboxymethylcellulose sodium, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, microcrystalline cellulose, monoammonium glycyrrhizinate, oleic acid, sorbitol, sucralose and sucrose.</Description>
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<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam USP is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam USP. The inactive ingredients in meloxicam tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate (trisodium citrate dihydrate).</Description>
</NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
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<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: : 1 Osteoarthritis (OA) (1.1) , 2 Rheumatoid Arthritis (RA) (1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam USP is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam USP. The inactive ingredients in meloxicam tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate (trisodium citrate dihydrate).</Description>
</NDC>
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<ProductNDC>16571-777</ProductNDC>
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<ProprietaryName>Meloxicam</ProprietaryName>
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<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: : 1 Osteoarthritis (OA) (1.1) , 2 Rheumatoid Arthritis (RA) (1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam USP is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam USP. The inactive ingredients in meloxicam tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate (trisodium citrate dihydrate).</Description>
</NDC>
<NDC>
<NDCCode>21695-777-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-777-30)</PackageDescription>
<NDC11Code>21695-0777-30</NDC11Code>
<ProductNDC>21695-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075155</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane.</Description>
</NDC>
<NDC>
<NDCCode>42291-777-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42291-777-30) </PackageDescription>
<NDC11Code>42291-0777-30</NDC11Code>
<ProductNDC>42291-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209745</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)] . Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2 R)-2-({2-[2-(2,2,2- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1 H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4 with a molecular weight of 495.53. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin capsules, 4 mg and 8 mg for oral administration contains 4 mg or 8 mg silodosin respectively and inactive ingredients: gelatin, mannitol, pregelatinized starch [Botanical source: corn (maize)], sodium lauryl sulphate, sodium stearyl fumarate and titanium dioxide. Each capsule of 4 mg and 8 mg are imprinted with gold pharmaceutical ink or green pharmaceutical ink respectively and contains: FD & C blue #2 aluminum lake (green pharmaceutical ink), butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, titanium dioxide (green pharmaceutical ink), and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>55700-777-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-777-30) </PackageDescription>
<NDC11Code>55700-0777-30</NDC11Code>
<ProductNDC>55700-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078148</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem Tartrate Extended-Release Tablets, USP, are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see CLINICAL STUDIES (14)].</IndicationAndUsage>
<Description>Zolpidem Tartrate Extended-Release Tablets, USP, contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class. Zolpidem tartrate extended-release tablets are available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Zolpidem tartrate extended-release tablets are film coated containing a hydrogel-matrix core that provides extended-release of the drug content. The 6.25 mg zolpidem tartrate extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C yellow #6/sunset yellow FCF aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, sugar, titanium dioxide and talc. The 12.5 mg zolpidem tartrate extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, sugar, titanium dioxide and triacetin. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>61919-777-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (61919-777-30)</PackageDescription>
<NDC11Code>61919-0777-30</NDC11Code>
<ProductNDC>61919-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090170</ApplicationNumber>
<LabelerName>Direct RX</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>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>1.1 Epilepsy. Adjunctive Therapy. Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age:partial seizuresprimary generalized tonic-clonic seizuresgeneralized seizures of Lennox-Gastaut syndrome. Monotherapy. Lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.2 Bipolar Disorder. Lamotrigine tablets are indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (≥18 years of age) treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established. The effectiveness of lamotrigine tablets as maintenance treatment was established in 2 placebo-controlled trials in patients with Bipolar I Disorder as defined by DSM-IV [see Clinical Studies (14.2)]. The physician who elects to prescribe lamotrigine tablets for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</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 to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:Lamotrigine tablets USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, the 200 mg tablets contain FD&C Blue No. 2 Lake.</Description>
</NDC>
<NDC>
<NDCCode>68462-777-35</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (68462-777-35) / 10 mL in 1 VIAL (68462-777-10) </PackageDescription>
<NDC11Code>68462-0777-35</NDC11Code>
<ProductNDC>68462-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION</RouteName>
<StartMarketingDate>20251008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219883</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection,USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W.328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>73581-777-20</NDCCode>
<PackageDescription>200 TABLET in 1 BOTTLE (73581-777-20) </PackageDescription>
<NDC11Code>73581-0777-20</NDC11Code>
<ProductNDC>73581-777</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibs Labs - Anti-diarrheal</ProprietaryName>
<ProprietaryNameSuffix>Original Prescription Strength, 2 Mg</ProprietaryNameSuffix>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076497</ApplicationNumber>
<LabelerName>YYBA</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73581-777-96</NDCCode>
<PackageDescription>96 TABLET in 1 BOTTLE (73581-777-96) </PackageDescription>
<NDC11Code>73581-0777-96</NDC11Code>
<ProductNDC>73581-777</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibs Labs - Anti-diarrheal</ProprietaryName>
<ProprietaryNameSuffix>Original Prescription Strength, 2 Mg</ProprietaryNameSuffix>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076497</ApplicationNumber>
<LabelerName>YYBA</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>80673-777-01</NDCCode>
<PackageDescription>1 CARTON in 1 BOX (80673-777-01) / 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) / 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01) </PackageDescription>
<NDC11Code>80673-0777-01</NDC11Code>
<ProductNDC>80673-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ebanga</ProprietaryName>
<NonProprietaryName>Ansuvimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761172</ApplicationNumber>
<LabelerName>Ridgeback Biotherapeutics, LP</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EBANGA is indicated for the treatment of infection caused by Zaire ebolavirusin adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirusinfection [see Dosage and Administration (2.2)and Clinical Studies (14)] .</IndicationAndUsage>
<Description>Ansuvimab-zykl is a Zaire ebolavirus(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6.</Description>
</NDC>
<NDC>
<NDCCode>80673-777-04</NDCCode>
<PackageDescription>4 CARTON in 1 BOX (80673-777-04) / 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) / 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01) </PackageDescription>
<NDC11Code>80673-0777-04</NDC11Code>
<ProductNDC>80673-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ebanga</ProprietaryName>
<NonProprietaryName>Ansuvimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761172</ApplicationNumber>
<LabelerName>Ridgeback Biotherapeutics, LP</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EBANGA is indicated for the treatment of infection caused by Zaire ebolavirusin adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirusinfection [see Dosage and Administration (2.2)and Clinical Studies (14)] .</IndicationAndUsage>
<Description>Ansuvimab-zykl is a Zaire ebolavirus(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6.</Description>
</NDC>
<NDC>
<NDCCode>80673-777-08</NDCCode>
<PackageDescription>8 CARTON in 1 BOX (80673-777-08) / 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) / 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01) </PackageDescription>
<NDC11Code>80673-0777-08</NDC11Code>
<ProductNDC>80673-777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ebanga</ProprietaryName>
<NonProprietaryName>Ansuvimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761172</ApplicationNumber>
<LabelerName>Ridgeback Biotherapeutics, LP</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EBANGA is indicated for the treatment of infection caused by Zaire ebolavirusin adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirusinfection [see Dosage and Administration (2.2)and Clinical Studies (14)] .</IndicationAndUsage>
<Description>Ansuvimab-zykl is a Zaire ebolavirus(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6.</Description>
</NDC>
<NDC>
<NDCCode>62037-524-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62037-524-01) </PackageDescription>
<NDC11Code>62037-0524-01</NDC11Code>
<ProductNDC>62037-524</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Ibuprofen</ProprietaryName>
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