{
"NDC": [
{
"NDCCode": "83257-029-41",
"PackageDescription": "1 SYRINGE in 1 CARTON (83257-029-41) / 1 mL in 1 SYRINGE",
"NDC11Code": "83257-0029-41",
"ProductNDC": "83257-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosaya",
"NonProprietaryName": "Denosumab-kyqq",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260105",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761436",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "DENOSUMAB",
"StrengthNumber": "60",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260105",
"SamplePackage": "N",
"Description": "Denosumab-kyqq is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-kyqq has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Bosaya (denosumab-kyqq) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL single-dose prefilled syringe of Bosaya contains 60 mg denosumab-kyqq, glacial acetic acid (0.234 mg),polysorbate 20 (0.1 mg), sodium acetate (1.075 mg), sorbitol (47 mg), Water for Injection (USP), and may contain sodium hydroxide/acetic acid to adjust pH of 5.2."
},
{
"NDCCode": "74934-029-01",
"PackageDescription": "50 PATCH in 1 BAG (74934-029-01) / 4.41 mL in 1 PATCH",
"NDC11Code": "74934-0029-01",
"ProductNDC": "74934-029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "American Bling Protective Disinfecting Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200718",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Zhejiang iColor Biotech Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".75",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200718",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on ths skin."
},
{
"NDCCode": "83257-005-41",
"PackageDescription": "1 SYRINGE in 1 CARTON (83257-005-41) / .6 mL in 1 SYRINGE",
"NDC11Code": "83257-0005-41",
"ProductNDC": "83257-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fulphila",
"NonProprietaryName": "Pegfilgrastim-jmdb",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761075",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "PEGFILGRASTIM",
"StrengthNumber": "6",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Fulphila is a leukocyte growth factor indicated to : 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) .",
"Description": "Pegfilgrastim-jmdb is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-jmdb a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-jmdb is approximately 39 kD. Fulphila (pegfilgrastim-jmdb) injection is intended for subcutaneous use only and is supplied in a single-dose prefilled syringe with a 29 gauge needle, with UltraSafe Passive Plus Needle Guard. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). The delivered 0.6 mL dose from the prefilled syringe contains 6 mg pegfilgrastim-jmdb (based on protein mass only) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.7 mg), D-sorbitol (30 mg), polysorbate 20 (0.024 mg) and sodium (0.01 mg) in Water for Injection, USP."
},
{
"NDCCode": "83257-023-41",
"PackageDescription": "1 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGE",
"NDC11Code": "83257-0023-41",
"ProductNDC": "83257-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yesintek",
"NonProprietaryName": "Ustekinumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761406",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250222",
"SamplePackage": "Y"
},
{
"NDCCode": "83257-025-41",
"PackageDescription": "1 SYRINGE in 1 CARTON (83257-025-41) / 1 mL in 1 SYRINGE",
"NDC11Code": "83257-0025-41",
"ProductNDC": "83257-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yesintek",
"NonProprietaryName": "Ustekinumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761406",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250222",
"SamplePackage": "N"
},
{
"NDCCode": "83257-035-41",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (83257-035-41) / .05 mL in 1 SYRINGE, GLASS",
"NDC11Code": "83257-0035-41",
"ProductNDC": "83257-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yesafili",
"NonProprietaryName": "Aflibercept-jbvf",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20260803",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761274",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "2",
"StrengthUnit": "mg/.05mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260803",
"SamplePackage": "N"
},
{
"NDCCode": "21695-029-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (21695-029-10)",
"NDC11Code": "21695-0029-10",
"ProductNDC": "21695-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cialis",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20031126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021368",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) (1.1).",
"Description": "CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "21695-029-16",
"PackageDescription": "16 TABLET, FILM COATED in 1 BOTTLE (21695-029-16)",
"NDC11Code": "21695-0029-16",
"ProductNDC": "21695-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cialis",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20031126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021368",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) (1.1).",
"Description": "CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "21695-029-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (21695-029-30)",
"NDC11Code": "21695-0029-30",
"ProductNDC": "21695-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cialis",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20031126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021368",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) (1.1).",
"Description": "CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "55700-029-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-029-30) ",
"NDC11Code": "55700-0029-30",
"ProductNDC": "55700-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201384",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130927",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±)cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP in an extended-release formulation. The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol. Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol."
},
{
"NDCCode": "60290-029-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (60290-029-01) ",
"NDC11Code": "60290-0029-01",
"ProductNDC": "60290-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211298",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41 The structural formula is:. The chemical designation Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-12aR)-.It is a white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "60290-029-02",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (60290-029-02) ",
"NDC11Code": "60290-0029-02",
"ProductNDC": "60290-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211298",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41 The structural formula is:. The chemical designation Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-12aR)-.It is a white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "60290-029-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (60290-029-03) ",
"NDC11Code": "60290-0029-03",
"ProductNDC": "60290-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211298",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41 The structural formula is:. The chemical designation Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-12aR)-.It is a white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "60290-029-04",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (60290-029-04) ",
"NDC11Code": "60290-0029-04",
"ProductNDC": "60290-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211298",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260424",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41 The structural formula is:. The chemical designation Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-12aR)-.It is a white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "61919-029-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (61919-029-10)",
"NDC11Code": "61919-0029-10",
"ProductNDC": "61919-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062713",
"LabelerName": "DIRECT RX",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide."
},
{
"NDCCode": "61919-029-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (61919-029-14)",
"NDC11Code": "61919-0029-14",
"ProductNDC": "61919-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062713",
"LabelerName": "DIRECT RX",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide."
},
{
"NDCCode": "61919-029-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (61919-029-20)",
"NDC11Code": "61919-0029-20",
"ProductNDC": "61919-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062713",
"LabelerName": "DIRECT RX",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide."
},
{
"NDCCode": "61919-029-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (61919-029-28)",
"NDC11Code": "61919-0029-28",
"ProductNDC": "61919-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062713",
"LabelerName": "DIRECT RX",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide."
},
{
"NDCCode": "61919-029-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (61919-029-30)",
"NDC11Code": "61919-0029-30",
"ProductNDC": "61919-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062713",
"LabelerName": "DIRECT RX",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide."
},
{
"NDCCode": "61919-029-40",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (61919-029-40)",
"NDC11Code": "61919-0029-40",
"ProductNDC": "61919-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062713",
"LabelerName": "DIRECT RX",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide."
},
{
"NDCCode": "71596-029-02",
"PackageDescription": "2 CONTAINER in 1 CARTON (71596-029-02) > 10 g in 1 CONTAINER (71596-029-01)",
"NDC11Code": "71596-0029-02",
"ProductNDC": "71596-029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Botanic Heal Boh Derma Defense Wave Cushion 02 Natural Beige",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Cj Olivenetworks Co., Ltd",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "1.41; .67; .4",
"StrengthUnit": "g/10g; g/10g; g/10g",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "83257-001-11",
"PackageDescription": "1 VIAL in 1 CARTON (83257-001-11) / 15 mL in 1 VIAL",
"NDC11Code": "83257-0001-11",
"ProductNDC": "83257-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ogivri",
"NonProprietaryName": "Trastuzumab-dkst",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761074",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "TRASTUZUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/7.4mL",
"Pharm_Classes": "HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6."
},
{
"NDCCode": "83257-003-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83257-003-01) / 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83257-0003-01",
"ProductNDC": "83257-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ogivri",
"NonProprietaryName": "Trastuzumab-dkst",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761074",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "TRASTUZUMAB",
"StrengthNumber": "420",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6."
},
{
"NDCCode": "83257-004-12",
"PackageDescription": "1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11) ",
"NDC11Code": "83257-0004-12",
"ProductNDC": "83257-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ogivri",
"NonProprietaryName": "Trastuzumab-dkst",
"DosageFormName": "KIT",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761074",
"LabelerName": "Biocon Biologics Inc.",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
"Description": "Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6."
},
{
"NDCCode": "83257-006-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83257-006-11) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83257-0006-11",
"ProductNDC": "83257-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Insulin Diluting Medium For Kirsty",
"NonProprietaryName": "Water",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761188",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "1",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250915",
"SamplePackage": "N",
"IndicationAndUsage": "KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH."
},
{
"NDCCode": "83257-007-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83257-007-11) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83257-0007-11",
"ProductNDC": "83257-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kirsty",
"NonProprietaryName": "Insulin Aspart-xjhz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761188",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250915",
"SamplePackage": "N",
"IndicationAndUsage": "KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH."
},
{
"NDCCode": "83257-008-32",
"PackageDescription": "5 SYRINGE in 1 CARTON (83257-008-32) / 3 mL in 1 SYRINGE (83257-008-31) ",
"NDC11Code": "83257-0008-32",
"ProductNDC": "83257-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kirsty",
"NonProprietaryName": "Insulin Aspart-xjhz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761188",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250915",
"SamplePackage": "N",
"IndicationAndUsage": "KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH."
},
{
"NDCCode": "83257-009-11",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (83257-009-11) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "83257-0009-11",
"ProductNDC": "83257-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jobevne",
"NonProprietaryName": "Bevacizumab-nwgd",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20250410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761175",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "BEVACIZUMAB",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250410",
"SamplePackage": "N",
"IndicationAndUsage": "Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .",
"Description": "Bevacizumab-nwgd is a vascular endothelial growth factor inhibitor. Bevacizumab-nwgd is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-nwgd has an approximate molecular weight of 149 kDa. Bevacizumab-nwgd is produced in a mammalian cell (Chinese Hamster Ovary) expression system. Jobevne (bevacizumab-nwgd) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Jobevne contains bevacizumab-nwgd at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-nwgd, dibasic sodium phosphate (1.2 mg), monobasic sodium phosphate (4.5 mg), polysorbate 20 (0.4 mg), trehalose (54.3 mg) and Water for Injection, USP. Sodium hydroxide and phosphoric acid may be used to adjust pH to 6.2 during manufacturing."
},
{
"NDCCode": "83257-010-11",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (83257-010-11) / 16 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "83257-0010-11",
"ProductNDC": "83257-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jobevne",
"NonProprietaryName": "Bevacizumab-nwgd",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20250410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761175",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "BEVACIZUMAB",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250410",
"SamplePackage": "N",
"IndicationAndUsage": "Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .",
"Description": "Bevacizumab-nwgd is a vascular endothelial growth factor inhibitor. Bevacizumab-nwgd is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-nwgd has an approximate molecular weight of 149 kDa. Bevacizumab-nwgd is produced in a mammalian cell (Chinese Hamster Ovary) expression system. Jobevne (bevacizumab-nwgd) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Jobevne contains bevacizumab-nwgd at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-nwgd, dibasic sodium phosphate (1.2 mg), monobasic sodium phosphate (4.5 mg), polysorbate 20 (0.4 mg), trehalose (54.3 mg) and Water for Injection, USP. Sodium hydroxide and phosphoric acid may be used to adjust pH to 6.2 during manufacturing."
},
{
"NDCCode": "83257-011-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83257-011-11) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83257-0011-11",
"ProductNDC": "83257-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Semglee",
"NonProprietaryName": "Insulin Glargine-yfgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230728",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761201",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230728",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.",
"Description": "Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>83257-029-41</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83257-029-41) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0029-41</NDC11Code>
<ProductNDC>83257-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosaya</ProprietaryName>
<NonProprietaryName>Denosumab-kyqq</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260105</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761436</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>DENOSUMAB</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Denosumab-kyqq is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-kyqq has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Bosaya (denosumab-kyqq) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL single-dose prefilled syringe of Bosaya contains 60 mg denosumab-kyqq, glacial acetic acid (0.234 mg),polysorbate 20 (0.1 mg), sodium acetate (1.075 mg), sorbitol (47 mg), Water for Injection (USP), and may contain sodium hydroxide/acetic acid to adjust pH of 5.2.</Description>
</NDC>
<NDC>
<NDCCode>74934-029-01</NDCCode>
<PackageDescription>50 PATCH in 1 BAG (74934-029-01) / 4.41 mL in 1 PATCH</PackageDescription>
<NDC11Code>74934-0029-01</NDC11Code>
<ProductNDC>74934-029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>American Bling Protective Disinfecting Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200718</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Zhejiang iColor Biotech Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200718</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on ths skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83257-005-41</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83257-005-41) / .6 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0005-41</NDC11Code>
<ProductNDC>83257-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fulphila</ProprietaryName>
<NonProprietaryName>Pegfilgrastim-jmdb</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761075</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>PEGFILGRASTIM</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fulphila is a leukocyte growth factor indicated to : 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) .</IndicationAndUsage>
<Description>Pegfilgrastim-jmdb is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-jmdb a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-jmdb is approximately 39 kD. Fulphila (pegfilgrastim-jmdb) injection is intended for subcutaneous use only and is supplied in a single-dose prefilled syringe with a 29 gauge needle, with UltraSafe Passive Plus Needle Guard. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). The delivered 0.6 mL dose from the prefilled syringe contains 6 mg pegfilgrastim-jmdb (based on protein mass only) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.7 mg), D-sorbitol (30 mg), polysorbate 20 (0.024 mg) and sodium (0.01 mg) in Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>83257-023-41</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0023-41</NDC11Code>
<ProductNDC>83257-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yesintek</ProprietaryName>
<NonProprietaryName>Ustekinumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250222</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761406</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250222</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>83257-025-41</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83257-025-41) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0025-41</NDC11Code>
<ProductNDC>83257-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yesintek</ProprietaryName>
<NonProprietaryName>Ustekinumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250222</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761406</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83257-035-41</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (83257-035-41) / .05 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>83257-0035-41</NDC11Code>
<ProductNDC>83257-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yesafili</ProprietaryName>
<NonProprietaryName>Aflibercept-jbvf</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20260803</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761274</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/.05mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21695-029-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (21695-029-10)</PackageDescription>
<NDC11Code>21695-0029-10</NDC11Code>
<ProductNDC>21695-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cialis</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021368</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) (1.1).</IndicationAndUsage>
<Description>CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>21695-029-16</NDCCode>
<PackageDescription>16 TABLET, FILM COATED in 1 BOTTLE (21695-029-16)</PackageDescription>
<NDC11Code>21695-0029-16</NDC11Code>
<ProductNDC>21695-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cialis</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021368</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) (1.1).</IndicationAndUsage>
<Description>CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>21695-029-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (21695-029-30)</PackageDescription>
<NDC11Code>21695-0029-30</NDC11Code>
<ProductNDC>21695-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cialis</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021368</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) (1.1).</IndicationAndUsage>
<Description>CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>55700-029-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-029-30) </PackageDescription>
<NDC11Code>55700-0029-30</NDC11Code>
<ProductNDC>55700-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201384</ApplicationNumber>
<LabelerName>Quality Care Products LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±)cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP in an extended-release formulation. The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol. Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>60290-029-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60290-029-01) </PackageDescription>
<NDC11Code>60290-0029-01</NDC11Code>
<ProductNDC>60290-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211298</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41 The structural formula is:. The chemical designation Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-12aR)-.It is a white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>60290-029-02</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (60290-029-02) </PackageDescription>
<NDC11Code>60290-0029-02</NDC11Code>
<ProductNDC>60290-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211298</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41 The structural formula is:. The chemical designation Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-12aR)-.It is a white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>60290-029-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (60290-029-03) </PackageDescription>
<NDC11Code>60290-0029-03</NDC11Code>
<ProductNDC>60290-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211298</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41 The structural formula is:. The chemical designation Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-12aR)-.It is a white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>60290-029-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (60290-029-04) </PackageDescription>
<NDC11Code>60290-0029-04</NDC11Code>
<ProductNDC>60290-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211298</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41 The structural formula is:. The chemical designation Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-12aR)-.It is a white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>61919-029-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (61919-029-10)</PackageDescription>
<NDC11Code>61919-0029-10</NDC11Code>
<ProductNDC>61919-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062713</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>61919-029-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (61919-029-14)</PackageDescription>
<NDC11Code>61919-0029-14</NDC11Code>
<ProductNDC>61919-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062713</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>61919-029-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (61919-029-20)</PackageDescription>
<NDC11Code>61919-0029-20</NDC11Code>
<ProductNDC>61919-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062713</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>61919-029-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (61919-029-28)</PackageDescription>
<NDC11Code>61919-0029-28</NDC11Code>
<ProductNDC>61919-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062713</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>61919-029-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (61919-029-30)</PackageDescription>
<NDC11Code>61919-0029-30</NDC11Code>
<ProductNDC>61919-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062713</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>61919-029-40</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (61919-029-40)</PackageDescription>
<NDC11Code>61919-0029-40</NDC11Code>
<ProductNDC>61919-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062713</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71596-029-02</NDCCode>
<PackageDescription>2 CONTAINER in 1 CARTON (71596-029-02) > 10 g in 1 CONTAINER (71596-029-01)</PackageDescription>
<NDC11Code>71596-0029-02</NDC11Code>
<ProductNDC>71596-029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Botanic Heal Boh Derma Defense Wave Cushion 02 Natural Beige</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Cj Olivenetworks Co., Ltd</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>1.41; .67; .4</StrengthNumber>
<StrengthUnit>g/10g; g/10g; g/10g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>83257-001-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (83257-001-11) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>83257-0001-11</NDC11Code>
<ProductNDC>83257-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ogivri</ProprietaryName>
<NonProprietaryName>Trastuzumab-dkst</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761074</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>TRASTUZUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/7.4mL</StrengthUnit>
<Pharm_Classes>HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>83257-003-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83257-003-01) / 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83257-0003-01</NDC11Code>
<ProductNDC>83257-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ogivri</ProprietaryName>
<NonProprietaryName>Trastuzumab-dkst</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761074</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>TRASTUZUMAB</SubstanceName>
<StrengthNumber>420</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>83257-004-12</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11) </PackageDescription>
<NDC11Code>83257-0004-12</NDC11Code>
<ProductNDC>83257-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ogivri</ProprietaryName>
<NonProprietaryName>Trastuzumab-dkst</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761074</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
<Description>Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6.</Description>
</NDC>
<NDC>
<NDCCode>83257-006-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83257-006-11) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83257-0006-11</NDC11Code>
<ProductNDC>83257-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Insulin Diluting Medium For Kirsty</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761188</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-007-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83257-007-11) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83257-0007-11</NDC11Code>
<ProductNDC>83257-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kirsty</ProprietaryName>
<NonProprietaryName>Insulin Aspart-xjhz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761188</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-008-32</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (83257-008-32) / 3 mL in 1 SYRINGE (83257-008-31) </PackageDescription>
<NDC11Code>83257-0008-32</NDC11Code>
<ProductNDC>83257-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kirsty</ProprietaryName>
<NonProprietaryName>Insulin Aspart-xjhz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761188</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris. Insulin aspart-xjhz has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83257-009-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (83257-009-11) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>83257-0009-11</NDC11Code>
<ProductNDC>83257-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jobevne</ProprietaryName>
<NonProprietaryName>Bevacizumab-nwgd</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20250410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761175</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>BEVACIZUMAB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .</IndicationAndUsage>
<Description>Bevacizumab-nwgd is a vascular endothelial growth factor inhibitor. Bevacizumab-nwgd is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-nwgd has an approximate molecular weight of 149 kDa. Bevacizumab-nwgd is produced in a mammalian cell (Chinese Hamster Ovary) expression system. Jobevne (bevacizumab-nwgd) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Jobevne contains bevacizumab-nwgd at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-nwgd, dibasic sodium phosphate (1.2 mg), monobasic sodium phosphate (4.5 mg), polysorbate 20 (0.4 mg), trehalose (54.3 mg) and Water for Injection, USP. Sodium hydroxide and phosphoric acid may be used to adjust pH to 6.2 during manufacturing.</Description>
</NDC>
<NDC>
<NDCCode>83257-010-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (83257-010-11) / 16 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>83257-0010-11</NDC11Code>
<ProductNDC>83257-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jobevne</ProprietaryName>
<NonProprietaryName>Bevacizumab-nwgd</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20250410</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761175</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>BEVACIZUMAB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of: : 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment. (1.1) , 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) .</IndicationAndUsage>
<Description>Bevacizumab-nwgd is a vascular endothelial growth factor inhibitor. Bevacizumab-nwgd is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-nwgd has an approximate molecular weight of 149 kDa. Bevacizumab-nwgd is produced in a mammalian cell (Chinese Hamster Ovary) expression system. Jobevne (bevacizumab-nwgd) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial for intravenous use. Jobevne contains bevacizumab-nwgd at a concentration of 25 mg/mL in either a 100 mg/4 mL or 400 mg/16 mL single-dose vial. Each mL of solution contains 25 mg bevacizumab-nwgd, dibasic sodium phosphate (1.2 mg), monobasic sodium phosphate (4.5 mg), polysorbate 20 (0.4 mg), trehalose (54.3 mg) and Water for Injection, USP. Sodium hydroxide and phosphoric acid may be used to adjust pH to 6.2 during manufacturing.</Description>
</NDC>
<NDC>
<NDCCode>83257-011-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83257-011-11) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83257-0011-11</NDC11Code>
<ProductNDC>83257-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Semglee</ProprietaryName>
<NonProprietaryName>Insulin Glargine-yfgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761201</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use. SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da. SEMGLEE (insulin glargine-yfgn) injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. SEMGLEE has a pH of approximately 4.</Description>
</NDC>
</NDCList>