{
"NDC": [
{
"NDCCode": "23070-8513-9",
"PackageDescription": "83486 TABLET in 1 CONTAINER (23070-8513-9) ",
"NDC11Code": "23070-8513-09",
"ProductNDC": "23070-8513",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET",
"StartMarketingDate": "20240709",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer Healthcare Manufacturing Srl",
"SubstanceName": "CIPROFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-09-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "09-JUL-24"
},
{
"NDCCode": "12527-8513-9",
"PackageDescription": "83486 TABLET, FILM COATED in 1 CONTAINER (12527-8513-9) ",
"NDC11Code": "12527-8513-09",
"ProductNDC": "12527-8513",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "19970826",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer AG",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-10-09",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "02-JUL-19"
},
{
"NDCCode": "0615-8513-39",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8513-39) ",
"NDC11Code": "00615-8513-39",
"ProductNDC": "0615-8513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209603",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240618",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, or 300 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "58597-8513-7",
"PackageDescription": "500 g in 1 BOTTLE (58597-8513-7)",
"NDC11Code": "58597-8513-07",
"ProductNDC": "58597-8513",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Lauryl Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140429",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AMERICAN PHARMACEUTICAL INGREDIENTS LLC",
"SubstanceName": "SODIUM LAURYL SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63629-8513-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (63629-8513-1) ",
"NDC11Code": "63629-8513-01",
"ProductNDC": "63629-8513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212517",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.",
"Description": "Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow round shaped tablets containing 250 mg naproxen, light yellow capsule shaped tablets containing 375 mg naproxen, and light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula:. Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH < 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate."
},
{
"NDCCode": "68788-8513-2",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (68788-8513-2) ",
"NDC11Code": "68788-8513-02",
"ProductNDC": "68788-8513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N"
},
{
"NDCCode": "68788-8513-3",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8513-3) ",
"NDC11Code": "68788-8513-03",
"ProductNDC": "68788-8513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N"
},
{
"NDCCode": "68788-8513-6",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8513-6) ",
"NDC11Code": "68788-8513-06",
"ProductNDC": "68788-8513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N"
},
{
"NDCCode": "0002-1401-71",
"PackageDescription": "9 TRAY in 1 BOX (0002-1401-71) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE",
"NDC11Code": "00002-1401-71",
"ProductNDC": "0002-1401",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Dulaglutide",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20140922",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DULAGLUTIDE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/.5mL",
"Status": "Unfinished",
"LastUpdate": "2025-12-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "22-SEP-14"
},
{
"NDCCode": "0002-1402-71",
"PackageDescription": "9 TRAY in 1 BOX (0002-1402-71) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE",
"NDC11Code": "00002-1402-71",
"ProductNDC": "0002-1402",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Dulaglutide",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20140922",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DULAGLUTIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/.5mL",
"Status": "Unfinished",
"LastUpdate": "2025-12-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "22-SEP-14"
},
{
"NDCCode": "0002-4178-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (0002-4178-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4178-01) ",
"NDC11Code": "00002-4178-31",
"ProductNDC": "0002-4178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foundayo",
"NonProprietaryName": "Orforglipron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220934",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ORFORGLIPRON CALCIUM",
"StrengthNumber": ".8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. ."
},
{
"NDCCode": "0002-4178-62",
"PackageDescription": "1 BOTTLE in 1 CARTON (0002-4178-62) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00002-4178-62",
"ProductNDC": "0002-4178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foundayo",
"NonProprietaryName": "Orforglipron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220934",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ORFORGLIPRON CALCIUM",
"StrengthNumber": ".8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "Y",
"IndicationAndUsage": "FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. ."
},
{
"NDCCode": "0002-4503-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (0002-4503-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4503-01) ",
"NDC11Code": "00002-4503-31",
"ProductNDC": "0002-4503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foundayo",
"NonProprietaryName": "Orforglipron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220934",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ORFORGLIPRON CALCIUM",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. ."
},
{
"NDCCode": "0002-4794-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (0002-4794-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4794-01) ",
"NDC11Code": "00002-4794-31",
"ProductNDC": "0002-4794",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foundayo",
"NonProprietaryName": "Orforglipron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220934",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ORFORGLIPRON CALCIUM",
"StrengthNumber": "5.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. ."
},
{
"NDCCode": "0002-4803-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (0002-4803-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4803-01) ",
"NDC11Code": "00002-4803-31",
"ProductNDC": "0002-4803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foundayo",
"NonProprietaryName": "Orforglipron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220934",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ORFORGLIPRON CALCIUM",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. ."
},
{
"NDCCode": "0002-4839-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (0002-4839-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4839-01) ",
"NDC11Code": "00002-4839-31",
"ProductNDC": "0002-4839",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foundayo",
"NonProprietaryName": "Orforglipron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220934",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ORFORGLIPRON CALCIUM",
"StrengthNumber": "14.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. ."
},
{
"NDCCode": "0002-4953-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (0002-4953-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4953-01) ",
"NDC11Code": "00002-4953-31",
"ProductNDC": "0002-4953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foundayo",
"NonProprietaryName": "Orforglipron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220934",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ORFORGLIPRON CALCIUM",
"StrengthNumber": "17.2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. ."
},
{
"NDCCode": "0002-7589-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7589-01) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-7589-01",
"ProductNDC": "0002-7589",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bebtelovimab",
"NonProprietaryName": "Bebtelovimab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220211",
"EndMarketingDate": "20240828",
"MarketingCategoryName": "EMERGENCY USE AUTHORIZATION",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "BEBTELOVIMAB",
"StrengthNumber": "87.5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-08-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220211",
"EndMarketingDatePackage": "20240828",
"SamplePackage": "N",
"Description": "Bebtelovimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 215 amino acids each and 2 identical heavy chain polypeptides composed of 449 amino acids produced by a Chinese Hamster Ovary (CHO) stable bulk culture or cell line with a molecular weight of 144 kDa. Bebtelovimab injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution in a single-dose vial for intravenous injection. Each mL contains 87.5 mg of bebtelovimab, L-histidine (0.4 mg), L-histidine hydrochloride monohydrate (0.6 mg), sodium chloride (2.9 mg), sucrose (60 mg), polysorbate 80 (0.5 mg), and Water for Injection. The bebtelovimab solution has a pH range of 5.5-6.5."
},
{
"NDCCode": "0002-7669-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7669-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-7669-01",
"ProductNDC": "0002-7669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyramza",
"NonProprietaryName": "Ramucirumab",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140421",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125477",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "RAMUCIRUMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "VEGFR2 Inhibitors [MoA], Vascular Endothelial Growth Factor Receptor 2 Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140421",
"SamplePackage": "N",
"IndicationAndUsage": "CYRAMZA® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated: : 1 as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. (1.1) , 2 in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. (1.2) , 3 in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. (1.2) , 4 in combination with FOLFIRI, for the treatment of adults with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. (1.3) , 5 as a single agent, for the treatment of adults with hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib. (1.4) .",
"Description": "Ramucirumab is a human VEGFR2 antagonist. It is a recombinant human IgG1 monoclonal antibody. Ramucirumab has an approximate molecular weight of 147 kDa. Ramucirumab is produced in genetically engineered mammalian NS0 cells. CYRAMZA (ramucirumab) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution. CYRAMZA is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-dose vials. CYRAMZA is formulated in glycine (9.98 mg/mL), histidine (0.65 mg/mL), histidine monohydrochloride (1.22 mg/mL), polysorbate 80 (0.1 mg/mL), sodium chloride (4.383 mg/mL), and Water for Injection, USP, pH 6.0."
},
{
"NDCCode": "0002-7678-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7678-01) / 50 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-7678-01",
"ProductNDC": "0002-7678",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyramza",
"NonProprietaryName": "Ramucirumab",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140421",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125477",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "RAMUCIRUMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "VEGFR2 Inhibitors [MoA], Vascular Endothelial Growth Factor Receptor 2 Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140421",
"SamplePackage": "N",
"IndicationAndUsage": "CYRAMZA® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated: : 1 as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. (1.1) , 2 in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. (1.2) , 3 in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. (1.2) , 4 in combination with FOLFIRI, for the treatment of adults with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. (1.3) , 5 as a single agent, for the treatment of adults with hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib. (1.4) .",
"Description": "Ramucirumab is a human VEGFR2 antagonist. It is a recombinant human IgG1 monoclonal antibody. Ramucirumab has an approximate molecular weight of 147 kDa. Ramucirumab is produced in genetically engineered mammalian NS0 cells. CYRAMZA (ramucirumab) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution. CYRAMZA is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-dose vials. CYRAMZA is formulated in glycine (9.98 mg/mL), histidine (0.65 mg/mL), histidine monohydrochloride (1.22 mg/mL), polysorbate 80 (0.1 mg/mL), sodium chloride (4.383 mg/mL), and Water for Injection, USP, pH 6.0."
},
{
"NDCCode": "0002-7716-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0002-7716-01) / 50 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00002-7716-01",
"ProductNDC": "0002-7716",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Portrazza",
"NonProprietaryName": "Necitumumab",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151124",
"EndMarketingDate": "20260527",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125547",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "NECITUMUMAB",
"StrengthNumber": "16",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Epidermal Growth Factor Receptor Antagonist [EPC], HER1 Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151124",
"EndMarketingDatePackage": "20260527",
"SamplePackage": "N",
"IndicationAndUsage": "PORTRAZZA is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. (1.1). Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer. (1.2, 5.6, 14.2).",
"Description": "Necitumumab is an anti-EGFR recombinant human monoclonal antibody of the IgG1 kappa isotype that specifically binds to the ligand binding site of the human EGFR. Necitumumab has an approximate molecular weight of 144.8 kDa. Necitumumab is produced in genetically engineered mammalian NS0 cells. PORTRAZZA is a sterile, preservative free, clear to slightly opalescent and colorless to slightly yellow solution. PORTRAZZA is available in single-dose vials for intravenous infusion following dilution. Each vial contains 800 mg PORTRAZZA in 50 mL (16 mg/mL). Each mL contains necitumumab (16 mg), citric acid anhydrous (0.256 mg), glycine (9.984 mg), mannitol (9.109 mg), polysorbate 80 (0.1 mg), sodium chloride (2.338 mg), sodium citrate dihydrate (2.55 mg), and water for injection, pH 6.0."
},
{
"NDCCode": "0002-7910-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7910-01) > 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-7910-01",
"ProductNDC": "0002-7910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bamlanivimab",
"NonProprietaryName": "Bamlanivimab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "EMERGENCY USE AUTHORIZATION",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "BAMLANIVIMAB",
"StrengthNumber": "35",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"Description": "Bamlanivimab. Bamlanivimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 214 amino acids each and 2 identical heavy chain polypeptides composed of 455 amino acids produced by a Chinese Hamster Ovary (CHO) cell line and molecular weight of 146 kDa. Bamlanivimab injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution in a vial for intravenous infusion. Each mL contains 35 mg of bamlanivimab, and L-histidine (0.4 mg), L-histidine hydrochloride monohydrate (0.6 mg), sodium chloride (2.9 mg), sucrose (60 mg), polysorbate 80 (0.5 mg), and Water for Injection. The bamlanivimab solution has a pH range of 5.5-6.5."
},
{
"NDCCode": "0002-7950-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7950-01) > 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-7950-01",
"ProductNDC": "0002-7950",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etesevimab",
"NonProprietaryName": "Etesevimab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "EMERGENCY USE AUTHORIZATION",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ETESEVIMAB",
"StrengthNumber": "35",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210209",
"SamplePackage": "N",
"Description": "Bamlanivimab. Bamlanivimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 214 amino acids each and 2 identical heavy chain polypeptides composed of 455 amino acids produced by a Chinese Hamster Ovary (CHO) cell line and molecular weight of 146 kDa. Bamlanivimab injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution in a vial for intravenous infusion. Each mL contains 35 mg of bamlanivimab, and L-histidine (0.4 mg), L-histidine hydrochloride monohydrate (0.6 mg), sodium chloride (2.9 mg), sucrose (60 mg), polysorbate 80 (0.5 mg), and Water for Injection. The bamlanivimab solution has a pH range of 5.5-6.5."
},
{
"NDCCode": "0002-8031-01",
"PackageDescription": "1 KIT in 1 KIT (0002-8031-01) * 1 mL in 1 VIAL (0002-7529-01) * 1 mL in 1 SYRINGE (0002-7530-01) ",
"NDC11Code": "00002-8031-01",
"ProductNDC": "0002-8031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glucagon",
"NonProprietaryName": "Glucagon",
"DosageFormName": "KIT",
"StartMarketingDate": "19990301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020928",
"LabelerName": "Eli Lilly and Company",
"Status": "Deprecated",
"LastUpdate": "2024-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19990301",
"EndMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "GLUCAGON for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: : 1 for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. (1.1) , 2 as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. (1.2) .",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is synthesized in a laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for glucagon. The chemical structure of the glucagon is identical to human glucagon. Glucagon is a single-chain polypeptide that contains 29 amino acid residues and has a molecular weight of 3483 Daltons. The empirical formula is C153H225N43O49S. The primary sequence of glucagon is shown below. Crystalline glucagon is a white to off-white powder. It is relatively insoluble in water but is soluble at a pH of less than 3 or more than 9.5. Glucagon for Injection is a sterile lyophilized white to off white powder in a vial and a syringe of sterile diluent for intravenous, intramuscular, or subcutaneous use. The vial contains 1 mg of glucagon, 49 mg of lactose monohydrate. Hydrochloric acid may have been added during manufacture to adjust the pH of the glucagon to 2.5 to 3.0. One International Unit of glucagon is equivalent to 1 mg of glucagon. The 1-mL diluent syringe contains 12 mg of glycerin, 1 mg hydrochloric acid, and Water for Injection, at pH 1.8 to 2.2."
},
{
"NDCCode": "0002-8147-01",
"PackageDescription": "1 TRAY in 1 CARTON (0002-8147-01) / 1 KIT in 1 TRAY * 2.88 mL in 1 CARTRIDGE (0002-7554-01) * 2.88 mL in 1 SYRINGE (0002-7618-01) ",
"NDC11Code": "00002-8147-01",
"ProductNDC": "0002-8147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humatrope",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20060127",
"EndMarketingDate": "20270616",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019640",
"LabelerName": "Eli Lilly and Company",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060127",
"EndMarketingDatePackage": "20270616",
"SamplePackage": "N",
"IndicationAndUsage": "HUMATROPE is a recombinant human growth hormone indicated for: : 1 Pediatric Patients: growth failure due to inadequate secretion of endogenous growth hormone (GH); short stature associated with Turner syndrome; Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. (1.1) , 2 Adult Patients: replacement of endogenous GH in adults with GH deficiency. (1.2) .",
"Description": "Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. HUMATROPE (somatropin) for injection is a sterile, white, lyophilized powder intended for subcutaneous injection after reconstitution supplied in a cartridge. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive. Cartridge — Each single-patient-use cartridge of HUMATROPE contains either 6 mg (18 IU), 12 mg (36 IU), or 24 mg (72 IU) of somatropin. Each HUMATROPE cartridge contains the following components (see Table 9):. Each cartridge is co-packaged with an accompanying syringe containing approximately 3 mL of diluent containing Water for Injection with 0.3% metacresol as a preservative and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24 mg cartridges, respectively."
},
{
"NDCCode": "0002-8148-01",
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"NDC11Code": "00002-8148-01",
"ProductNDC": "0002-8148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humatrope",
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"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
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"EndMarketingDate": "20270522",
"MarketingCategoryName": "BLA",
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"LabelerName": "Eli Lilly and Company",
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"IndicationAndUsage": "HUMATROPE is a recombinant human growth hormone indicated for: : 1 Pediatric Patients: growth failure due to inadequate secretion of endogenous growth hormone (GH); short stature associated with Turner syndrome; Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. (1.1) , 2 Adult Patients: replacement of endogenous GH in adults with GH deficiency. (1.2) .",
"Description": "Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. HUMATROPE (somatropin) for injection is a sterile, white, lyophilized powder intended for subcutaneous injection after reconstitution supplied in a cartridge. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive. Cartridge — Each single-patient-use cartridge of HUMATROPE contains either 6 mg (18 IU), 12 mg (36 IU), or 24 mg (72 IU) of somatropin. Each HUMATROPE cartridge contains the following components (see Table 9):. Each cartridge is co-packaged with an accompanying syringe containing approximately 3 mL of diluent containing Water for Injection with 0.3% metacresol as a preservative and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24 mg cartridges, respectively."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humatrope",
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"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20060127",
"EndMarketingDate": "20270529",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA019640",
"LabelerName": "Eli Lilly and Company",
"Status": "Active",
"LastUpdate": "2026-09-01",
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"IndicationAndUsage": "HUMATROPE is a recombinant human growth hormone indicated for: : 1 Pediatric Patients: growth failure due to inadequate secretion of endogenous growth hormone (GH); short stature associated with Turner syndrome; Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. (1.1) , 2 Adult Patients: replacement of endogenous GH in adults with GH deficiency. (1.2) .",
"Description": "Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. HUMATROPE (somatropin) for injection is a sterile, white, lyophilized powder intended for subcutaneous injection after reconstitution supplied in a cartridge. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive. Cartridge — Each single-patient-use cartridge of HUMATROPE contains either 6 mg (18 IU), 12 mg (36 IU), or 24 mg (72 IU) of somatropin. Each HUMATROPE cartridge contains the following components (see Table 9):. Each cartridge is co-packaged with an accompanying syringe containing approximately 3 mL of diluent containing Water for Injection with 0.3% metacresol as a preservative and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24 mg cartridges, respectively."
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"ProductNDC": "0003-0293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kenalog-40",
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"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRA-ARTICULAR; INTRAMUSCULAR",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014901",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
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"LastUpdate": "2024-08-23",
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"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "E.R. Squibb & Sons, L.L.C.",
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"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol."
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"Description": "KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol."
}
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.</IndicationAndUsage>
<Description>Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow round shaped tablets containing 250 mg naproxen, light yellow capsule shaped tablets containing 375 mg naproxen, and light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula:. Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH < 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>68788-8513-2</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (68788-8513-2) </PackageDescription>
<NDC11Code>68788-8513-02</NDC11Code>
<ProductNDC>68788-8513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-8513-3</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (68788-8513-3) </PackageDescription>
<NDC11Code>68788-8513-03</NDC11Code>
<ProductNDC>68788-8513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-8513-6</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68788-8513-6) </PackageDescription>
<NDC11Code>68788-8513-06</NDC11Code>
<ProductNDC>68788-8513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0002-1401-71</NDCCode>
<PackageDescription>9 TRAY in 1 BOX (0002-1401-71) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-1401-71</NDC11Code>
<ProductNDC>0002-1401</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dulaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20140922</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>DULAGLUTIDE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-SEP-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0002-1402-71</NDCCode>
<PackageDescription>9 TRAY in 1 BOX (0002-1402-71) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-1402-71</NDC11Code>
<ProductNDC>0002-1402</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dulaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20140922</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>DULAGLUTIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-SEP-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0002-4178-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4178-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4178-01) </PackageDescription>
<NDC11Code>00002-4178-31</NDC11Code>
<ProductNDC>0002-4178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
<NDC>
<NDCCode>0002-4178-62</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4178-62) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00002-4178-62</NDC11Code>
<ProductNDC>0002-4178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
<NDC>
<NDCCode>0002-4503-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4503-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4503-01) </PackageDescription>
<NDC11Code>00002-4503-31</NDC11Code>
<ProductNDC>0002-4503</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
<NDC>
<NDCCode>0002-4794-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4794-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4794-01) </PackageDescription>
<NDC11Code>00002-4794-31</NDC11Code>
<ProductNDC>0002-4794</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>5.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
<NDC>
<NDCCode>0002-4803-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4803-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4803-01) </PackageDescription>
<NDC11Code>00002-4803-31</NDC11Code>
<ProductNDC>0002-4803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
<NDC>
<NDCCode>0002-4839-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4839-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4839-01) </PackageDescription>
<NDC11Code>00002-4839-31</NDC11Code>
<ProductNDC>0002-4839</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>14.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
<NDC>
<NDCCode>0002-4953-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4953-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4953-01) </PackageDescription>
<NDC11Code>00002-4953-31</NDC11Code>
<ProductNDC>0002-4953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>17.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
<NDC>
<NDCCode>0002-7589-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7589-01) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-7589-01</NDC11Code>
<ProductNDC>0002-7589</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bebtelovimab</ProprietaryName>
<NonProprietaryName>Bebtelovimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220211</StartMarketingDate>
<EndMarketingDate>20240828</EndMarketingDate>
<MarketingCategoryName>EMERGENCY USE AUTHORIZATION</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>BEBTELOVIMAB</SubstanceName>
<StrengthNumber>87.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-08-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220211</StartMarketingDatePackage>
<EndMarketingDatePackage>20240828</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Bebtelovimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 215 amino acids each and 2 identical heavy chain polypeptides composed of 449 amino acids produced by a Chinese Hamster Ovary (CHO) stable bulk culture or cell line with a molecular weight of 144 kDa. Bebtelovimab injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution in a single-dose vial for intravenous injection. Each mL contains 87.5 mg of bebtelovimab, L-histidine (0.4 mg), L-histidine hydrochloride monohydrate (0.6 mg), sodium chloride (2.9 mg), sucrose (60 mg), polysorbate 80 (0.5 mg), and Water for Injection. The bebtelovimab solution has a pH range of 5.5-6.5.</Description>
</NDC>
<NDC>
<NDCCode>0002-7669-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7669-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-7669-01</NDC11Code>
<ProductNDC>0002-7669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyramza</ProprietaryName>
<NonProprietaryName>Ramucirumab</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140421</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125477</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>RAMUCIRUMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>VEGFR2 Inhibitors [MoA], Vascular Endothelial Growth Factor Receptor 2 Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CYRAMZA® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated: : 1 as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. (1.1) , 2 in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. (1.2) , 3 in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. (1.2) , 4 in combination with FOLFIRI, for the treatment of adults with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. (1.3) , 5 as a single agent, for the treatment of adults with hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib. (1.4) .</IndicationAndUsage>
<Description>Ramucirumab is a human VEGFR2 antagonist. It is a recombinant human IgG1 monoclonal antibody. Ramucirumab has an approximate molecular weight of 147 kDa. Ramucirumab is produced in genetically engineered mammalian NS0 cells. CYRAMZA (ramucirumab) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution. CYRAMZA is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-dose vials. CYRAMZA is formulated in glycine (9.98 mg/mL), histidine (0.65 mg/mL), histidine monohydrochloride (1.22 mg/mL), polysorbate 80 (0.1 mg/mL), sodium chloride (4.383 mg/mL), and Water for Injection, USP, pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0002-7678-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7678-01) / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-7678-01</NDC11Code>
<ProductNDC>0002-7678</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyramza</ProprietaryName>
<NonProprietaryName>Ramucirumab</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140421</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125477</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>RAMUCIRUMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>VEGFR2 Inhibitors [MoA], Vascular Endothelial Growth Factor Receptor 2 Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CYRAMZA® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated: : 1 as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. (1.1) , 2 in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. (1.2) , 3 in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. (1.2) , 4 in combination with FOLFIRI, for the treatment of adults with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. (1.3) , 5 as a single agent, for the treatment of adults with hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib. (1.4) .</IndicationAndUsage>
<Description>Ramucirumab is a human VEGFR2 antagonist. It is a recombinant human IgG1 monoclonal antibody. Ramucirumab has an approximate molecular weight of 147 kDa. Ramucirumab is produced in genetically engineered mammalian NS0 cells. CYRAMZA (ramucirumab) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution. CYRAMZA is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-dose vials. CYRAMZA is formulated in glycine (9.98 mg/mL), histidine (0.65 mg/mL), histidine monohydrochloride (1.22 mg/mL), polysorbate 80 (0.1 mg/mL), sodium chloride (4.383 mg/mL), and Water for Injection, USP, pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0002-7716-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0002-7716-01) / 50 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00002-7716-01</NDC11Code>
<ProductNDC>0002-7716</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Portrazza</ProprietaryName>
<NonProprietaryName>Necitumumab</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151124</StartMarketingDate>
<EndMarketingDate>20260527</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125547</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>NECITUMUMAB</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Epidermal Growth Factor Receptor Antagonist [EPC], HER1 Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151124</StartMarketingDatePackage>
<EndMarketingDatePackage>20260527</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PORTRAZZA is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. (1.1). Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer. (1.2, 5.6, 14.2).</IndicationAndUsage>
<Description>Necitumumab is an anti-EGFR recombinant human monoclonal antibody of the IgG1 kappa isotype that specifically binds to the ligand binding site of the human EGFR. Necitumumab has an approximate molecular weight of 144.8 kDa. Necitumumab is produced in genetically engineered mammalian NS0 cells. PORTRAZZA is a sterile, preservative free, clear to slightly opalescent and colorless to slightly yellow solution. PORTRAZZA is available in single-dose vials for intravenous infusion following dilution. Each vial contains 800 mg PORTRAZZA in 50 mL (16 mg/mL). Each mL contains necitumumab (16 mg), citric acid anhydrous (0.256 mg), glycine (9.984 mg), mannitol (9.109 mg), polysorbate 80 (0.1 mg), sodium chloride (2.338 mg), sodium citrate dihydrate (2.55 mg), and water for injection, pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0002-7910-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7910-01) > 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-7910-01</NDC11Code>
<ProductNDC>0002-7910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bamlanivimab</ProprietaryName>
<NonProprietaryName>Bamlanivimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201109</StartMarketingDate>
<MarketingCategoryName>EMERGENCY USE AUTHORIZATION</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>BAMLANIVIMAB</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Bamlanivimab. Bamlanivimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 214 amino acids each and 2 identical heavy chain polypeptides composed of 455 amino acids produced by a Chinese Hamster Ovary (CHO) cell line and molecular weight of 146 kDa. Bamlanivimab injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution in a vial for intravenous infusion. Each mL contains 35 mg of bamlanivimab, and L-histidine (0.4 mg), L-histidine hydrochloride monohydrate (0.6 mg), sodium chloride (2.9 mg), sucrose (60 mg), polysorbate 80 (0.5 mg), and Water for Injection. The bamlanivimab solution has a pH range of 5.5-6.5.</Description>
</NDC>
<NDC>
<NDCCode>0002-7950-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-7950-01) > 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-7950-01</NDC11Code>
<ProductNDC>0002-7950</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etesevimab</ProprietaryName>
<NonProprietaryName>Etesevimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>EMERGENCY USE AUTHORIZATION</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ETESEVIMAB</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Bamlanivimab. Bamlanivimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 214 amino acids each and 2 identical heavy chain polypeptides composed of 455 amino acids produced by a Chinese Hamster Ovary (CHO) cell line and molecular weight of 146 kDa. Bamlanivimab injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution in a vial for intravenous infusion. Each mL contains 35 mg of bamlanivimab, and L-histidine (0.4 mg), L-histidine hydrochloride monohydrate (0.6 mg), sodium chloride (2.9 mg), sucrose (60 mg), polysorbate 80 (0.5 mg), and Water for Injection. The bamlanivimab solution has a pH range of 5.5-6.5.</Description>
</NDC>
<NDC>
<NDCCode>0002-8031-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0002-8031-01) * 1 mL in 1 VIAL (0002-7529-01) * 1 mL in 1 SYRINGE (0002-7530-01) </PackageDescription>
<NDC11Code>00002-8031-01</NDC11Code>
<ProductNDC>0002-8031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glucagon</ProprietaryName>
<NonProprietaryName>Glucagon</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19990301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020928</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990301</StartMarketingDatePackage>
<EndMarketingDatePackage>20240102</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GLUCAGON for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: : 1 for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. (1.1) , 2 as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. (1.2) .</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is synthesized in a laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for glucagon. The chemical structure of the glucagon is identical to human glucagon. Glucagon is a single-chain polypeptide that contains 29 amino acid residues and has a molecular weight of 3483 Daltons. The empirical formula is C153H225N43O49S. The primary sequence of glucagon is shown below. Crystalline glucagon is a white to off-white powder. It is relatively insoluble in water but is soluble at a pH of less than 3 or more than 9.5. Glucagon for Injection is a sterile lyophilized white to off white powder in a vial and a syringe of sterile diluent for intravenous, intramuscular, or subcutaneous use. The vial contains 1 mg of glucagon, 49 mg of lactose monohydrate. Hydrochloric acid may have been added during manufacture to adjust the pH of the glucagon to 2.5 to 3.0. One International Unit of glucagon is equivalent to 1 mg of glucagon. The 1-mL diluent syringe contains 12 mg of glycerin, 1 mg hydrochloric acid, and Water for Injection, at pH 1.8 to 2.2.</Description>
</NDC>
<NDC>
<NDCCode>0002-8147-01</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0002-8147-01) / 1 KIT in 1 TRAY * 2.88 mL in 1 CARTRIDGE (0002-7554-01) * 2.88 mL in 1 SYRINGE (0002-7618-01) </PackageDescription>
<NDC11Code>00002-8147-01</NDC11Code>
<ProductNDC>0002-8147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humatrope</ProprietaryName>
<NonProprietaryName>Somatropin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060127</StartMarketingDate>
<EndMarketingDate>20270616</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA019640</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060127</StartMarketingDatePackage>
<EndMarketingDatePackage>20270616</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMATROPE is a recombinant human growth hormone indicated for: : 1 Pediatric Patients: growth failure due to inadequate secretion of endogenous growth hormone (GH); short stature associated with Turner syndrome; Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. (1.1) , 2 Adult Patients: replacement of endogenous GH in adults with GH deficiency. (1.2) .</IndicationAndUsage>
<Description>Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. HUMATROPE (somatropin) for injection is a sterile, white, lyophilized powder intended for subcutaneous injection after reconstitution supplied in a cartridge. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive. Cartridge — Each single-patient-use cartridge of HUMATROPE contains either 6 mg (18 IU), 12 mg (36 IU), or 24 mg (72 IU) of somatropin. Each HUMATROPE cartridge contains the following components (see Table 9):. Each cartridge is co-packaged with an accompanying syringe containing approximately 3 mL of diluent containing Water for Injection with 0.3% metacresol as a preservative and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24 mg cartridges, respectively.</Description>
</NDC>
<NDC>
<NDCCode>0002-8148-01</NDCCode>
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<IndicationAndUsage>HUMATROPE is a recombinant human growth hormone indicated for: : 1 Pediatric Patients: growth failure due to inadequate secretion of endogenous growth hormone (GH); short stature associated with Turner syndrome; Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. (1.1) , 2 Adult Patients: replacement of endogenous GH in adults with GH deficiency. (1.2) .</IndicationAndUsage>
<Description>Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. HUMATROPE (somatropin) for injection is a sterile, white, lyophilized powder intended for subcutaneous injection after reconstitution supplied in a cartridge. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive. Cartridge — Each single-patient-use cartridge of HUMATROPE contains either 6 mg (18 IU), 12 mg (36 IU), or 24 mg (72 IU) of somatropin. Each HUMATROPE cartridge contains the following components (see Table 9):. Each cartridge is co-packaged with an accompanying syringe containing approximately 3 mL of diluent containing Water for Injection with 0.3% metacresol as a preservative and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24 mg cartridges, respectively.</Description>
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<IndicationAndUsage>HUMATROPE is a recombinant human growth hormone indicated for: : 1 Pediatric Patients: growth failure due to inadequate secretion of endogenous growth hormone (GH); short stature associated with Turner syndrome; Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. (1.1) , 2 Adult Patients: replacement of endogenous GH in adults with GH deficiency. (1.2) .</IndicationAndUsage>
<Description>Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. HUMATROPE (somatropin) for injection is a sterile, white, lyophilized powder intended for subcutaneous injection after reconstitution supplied in a cartridge. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive. Cartridge — Each single-patient-use cartridge of HUMATROPE contains either 6 mg (18 IU), 12 mg (36 IU), or 24 mg (72 IU) of somatropin. Each HUMATROPE cartridge contains the following components (see Table 9):. Each cartridge is co-packaged with an accompanying syringe containing approximately 3 mL of diluent containing Water for Injection with 0.3% metacresol as a preservative and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24 mg cartridges, respectively.</Description>
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<IndicationAndUsage>Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol.</Description>
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<IndicationAndUsage>Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol.</Description>
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<IndicationAndUsage>Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>KENALOG®-40 Injection and KENALOG®-80 Injection (triamcinolone acetonide injectable suspension, USP) are a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. KENALOG®-40 Injection: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. KENALOG®-80 Injection: Each mL of the sterile aqueous suspension provides 80 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is. practically insoluble in water and very soluble in alcohol.</Description>
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