{
"NDC": [
{
"NDCCode": "0006-5030-02",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0006-5030-02) ",
"NDC11Code": "00006-5030-02",
"ProductNDC": "0006-5030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verquvo",
"NonProprietaryName": "Vericiguat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214377",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "VERICIGUAT",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "VERQUVO® is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% [see Clinical Studies (14)].",
"Description": "VERQUVO tablets contains vericiguat, a soluble guanylate cyclase stimulator. The chemical name of vericiguat is methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl] pyrimidin-5-yl} carbamate. The molecular formula is C19H16F2N8O2 and the molecular weight is 426.39 g/mol. The chemical structure is. Vericiguat is a white to yellowish powder that is freely soluble in dimethyl sulfoxide; slightly soluble in acetone; very slightly soluble in ethanol, acetonitrile, methanol, and ethyl acetate; and practically insoluble in 2-propanol. VERQUVO® is available as film-coated tablets for oral administration, containing 2.5 mg of vericiguat, 5 mg of vericiguat or 10 mg of vericiguat.The tablet inactive ingredients are croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains hypromellose, talc and titanium dioxide. The film coating for the 5 mg of VERQUVO tablet also contains ferric oxide red. The film coating for the 10 mg of VERQUVO tablet also contains ferric oxide yellow."
},
{
"NDCCode": "0006-5030-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5030-01) ",
"NDC11Code": "00006-5030-01",
"ProductNDC": "0006-5030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verquvo",
"NonProprietaryName": "Vericiguat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214377",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "VERICIGUAT",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "VERQUVO® is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% [see Clinical Studies (14)].",
"Description": "VERQUVO tablets contains vericiguat, a soluble guanylate cyclase stimulator. The chemical name of vericiguat is methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl] pyrimidin-5-yl} carbamate. The molecular formula is C19H16F2N8O2 and the molecular weight is 426.39 g/mol. The chemical structure is. Vericiguat is a white to yellowish powder that is freely soluble in dimethyl sulfoxide; slightly soluble in acetone; very slightly soluble in ethanol, acetonitrile, methanol, and ethyl acetate; and practically insoluble in 2-propanol. VERQUVO® is available as film-coated tablets for oral administration, containing 2.5 mg of vericiguat, 5 mg of vericiguat or 10 mg of vericiguat.The tablet inactive ingredients are croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains hypromellose, talc and titanium dioxide. The film coating for the 5 mg of VERQUVO tablet also contains ferric oxide red. The film coating for the 10 mg of VERQUVO tablet also contains ferric oxide yellow."
},
{
"NDCCode": "0006-5030-03",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0006-5030-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00006-5030-03",
"ProductNDC": "0006-5030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verquvo",
"NonProprietaryName": "Vericiguat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214377",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "VERICIGUAT",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N"
},
{
"NDCCode": "0006-5030-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0006-5030-04) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0006-5030-03) ",
"NDC11Code": "00006-5030-04",
"ProductNDC": "0006-5030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verquvo",
"NonProprietaryName": "Vericiguat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214377",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "VERICIGUAT",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "VERQUVO® is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% [see Clinical Studies (14)].",
"Description": "VERQUVO tablets contains vericiguat, a soluble guanylate cyclase stimulator. The chemical name of vericiguat is methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl] pyrimidin-5-yl} carbamate. The molecular formula is C19H16F2N8O2 and the molecular weight is 426.39 g/mol. The chemical structure is. Vericiguat is a white to yellowish powder that is freely soluble in dimethyl sulfoxide; slightly soluble in acetone; very slightly soluble in ethanol, acetonitrile, methanol, and ethyl acetate; and practically insoluble in 2-propanol. VERQUVO® is available as film-coated tablets for oral administration, containing 2.5 mg of vericiguat, 5 mg of vericiguat or 10 mg of vericiguat.The tablet inactive ingredients are croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains hypromellose, talc and titanium dioxide. The film coating for the 5 mg of VERQUVO tablet also contains ferric oxide red. The film coating for the 10 mg of VERQUVO tablet also contains ferric oxide yellow."
},
{
"NDCCode": "0009-5030-02",
"PackageDescription": "1 BAG in 1 DRUM (0009-5030-02) > 25 kg in 1 BAG",
"NDC11Code": "00009-5030-02",
"ProductNDC": "0009-5030",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140703",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pharmacia and Upjohn Company LLC",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2020-11-25",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "10875-5030-2",
"PackageDescription": "891.31 kg in 1 CONTAINER (10875-5030-2)",
"NDC11Code": "10875-5030-02",
"ProductNDC": "10875-5030",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mineral",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140626",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Calumet Karns City Refining LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "57955-5030-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-5030-2)",
"NDC11Code": "57955-5030-02",
"ProductNDC": "57955-5030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sciatici Freee",
"NonProprietaryName": "Natural Medicine",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110613",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Kingbio",
"SubstanceName": "HORSE CHESTNUT; AMMONIUM CHLORIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAPSICUM; CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; PSEUDOGNAPHALIUM OBTUSIFOLIUM; STRYCHNOS IGNATII SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Indications and usage. Reference image of sciatic freee.jpg."
},
{
"NDCCode": "63083-5030-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-5030-2) ",
"NDC11Code": "63083-5030-02",
"ProductNDC": "63083-5030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tonsil/adenoid/appendix Drops",
"ProprietaryNameSuffix": "5030",
"NonProprietaryName": "Tonsil/adenoid/appendix Drops",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "BERBERIS AQUIFOLIUM ROOT BARK; ECHINACEA ANGUSTIFOLIA WHOLE; SUS SCROFA LYMPH; SUS SCROFA COLON; BOS TAURUS TONSIL",
"StrengthNumber": "3; 3; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "10875-5030-1",
"PackageDescription": "181.44 kg in 1 DRUM (10875-5030-1)",
"NDC11Code": "10875-5030-01",
"ProductNDC": "10875-5030",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mineral",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140626",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Calumet Karns City Refining LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "10875-5030-3",
"PackageDescription": "20411.66 kg in 1 TANK (10875-5030-3)",
"NDC11Code": "10875-5030-03",
"ProductNDC": "10875-5030",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mineral",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140626",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Calumet Karns City Refining LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "10875-5030-4",
"PackageDescription": "72574.79 kg in 1 TANK (10875-5030-4)",
"NDC11Code": "10875-5030-04",
"ProductNDC": "10875-5030",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mineral",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140626",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Calumet Karns City Refining LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "62670-5030-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-5030-0)",
"NDC11Code": "62670-5030-00",
"ProductNDC": "62670-5030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Mango Dragonfruit",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160217",
"EndMarketingDate": "20160817",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0006-0007-02",
"PackageDescription": "1 BAG in 1 DRUM (0006-0007-02) > 50 kg in 1 BAG",
"NDC11Code": "00006-0007-02",
"ProductNDC": "0006-0007",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Carbidopa",
"DosageFormName": "POWDER",
"StartMarketingDate": "19750502",
"MarketingCategoryName": "EXPORT ONLY",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "CARBIDOPA",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "0006-0277-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 DOSE PACK (0006-0277-02) ",
"NDC11Code": "00006-0277-02",
"ProductNDC": "0006-0277",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Januvia",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021995",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061016",
"SamplePackage": "N",
"IndicationAndUsage": "JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide."
},
{
"NDCCode": "0006-0461-02",
"PackageDescription": "2 CAPSULE in 1 DOSE PACK (0006-0461-02) ",
"NDC11Code": "00006-0461-02",
"ProductNDC": "0006-0461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emend",
"NonProprietaryName": "Aprepitant",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20030326",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021549",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "APREPITANT",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030326",
"SamplePackage": "N",
"IndicationAndUsage": "EMEND® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).",
"Description": "EMEND capsules contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 80 mg or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 125-mg capsule also contains red ferric oxide and yellow ferric oxide. Each pouch of EMEND for oral suspension 125 mg contains 125 mg of aprepitant and the following inactive ingredients: sucrose, lactose, hydroxypropyl cellulose, sodium lauryl sulfate, red iron oxide, and sodium stearyl fumarate."
},
{
"NDCCode": "0006-0575-03",
"PackageDescription": "2 BOTTLE in 1 CARTON (0006-0575-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0575-02) ",
"NDC11Code": "00006-0575-03",
"ProductNDC": "0006-0575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Janumet",
"NonProprietaryName": "Sitagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070330",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022044",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "50; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070330",
"SamplePackage": "Y",
"IndicationAndUsage": "JANUMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET [see Warnings and Precautions (5.2)].",
"Description": "JANUMET (sitagliptin and metformin HCl) tablets for oral use contain two antihyperglycemic drugs: sitagliptin and metformin HCl."
},
{
"NDCCode": "0006-0577-03",
"PackageDescription": "2 BOTTLE in 1 CARTON (0006-0577-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0577-02) ",
"NDC11Code": "00006-0577-03",
"ProductNDC": "0006-0577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Janumet",
"NonProprietaryName": "Sitagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070330",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022044",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "50; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070330",
"SamplePackage": "Y",
"IndicationAndUsage": "JANUMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET [see Warnings and Precautions (5.2)].",
"Description": "JANUMET (sitagliptin and metformin HCl) tablets for oral use contain two antihyperglycemic drugs: sitagliptin and metformin HCl."
},
{
"NDCCode": "0006-3026-02",
"PackageDescription": "1 VIAL in 1 CARTON (0006-3026-02) / 4 mL in 1 VIAL (0006-3026-01) ",
"NDC11Code": "00006-3026-02",
"ProductNDC": "0006-3026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Keytruda",
"NonProprietaryName": "Pembrolizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125514",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "PEMBROLIZUMAB",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150115",
"SamplePackage": "N",
"IndicationAndUsage": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:. Melanoma: 1 for the treatment of patients with unresectable or metastatic melanoma. (1.1), 2 for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. (1.1).",
"Description": "Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells. KEYTRUDA (pembrolizumab) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous use. Each vial contains 100 mg of pembrolizumab in 4 mL of solution. Each 1 mL of solution contains 25 mg of pembrolizumab and is formulated in: L-histidine (1.55 mg), polysorbate 80 (0.2 mg), sucrose (70 mg), and Water for Injection, USP."
},
{
"NDCCode": "0006-3029-02",
"PackageDescription": "1 VIAL in 1 CARTON (0006-3029-02) > 15 mL in 1 VIAL (0006-3029-01) ",
"NDC11Code": "00006-3029-02",
"ProductNDC": "0006-3029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Keytruda",
"NonProprietaryName": "Pembrolizumab",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140904",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125514",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "PEMBROLIZUMAB",
"StrengthNumber": "50",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140904",
"SamplePackage": "N"
},
{
"NDCCode": "0006-3061-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-02) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-03) ",
"NDC11Code": "00006-3061-02",
"ProductNDC": "0006-3061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emend",
"NonProprietaryName": "Fosaprepitant Dimeglumine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022023",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "FOSAPREPITANT DIMEGLUMINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170203",
"SamplePackage": "N"
},
{
"NDCCode": "0006-3074-02",
"PackageDescription": "2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01) ",
"NDC11Code": "00006-3074-02",
"ProductNDC": "0006-3074",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zepatier",
"NonProprietaryName": "Elbasvir And Grazoprevir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160128",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208261",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ELBASVIR; GRAZOPREVIR ANHYDROUS",
"StrengthNumber": "50; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160128",
"SamplePackage": "N",
"IndicationAndUsage": "ZEPATIER® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2)].",
"Description": "ZEPATIER is a fixed-dose combination tablet containing elbasvir and grazoprevir for oral administration. Elbasvir is an HCV NS5A inhibitor, and grazoprevir is an HCV NS3/4A protease inhibitor. Each tablet contains 50 mg elbasvir and 100 mg grazoprevir. The tablets include the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, sodium chloride, sodium lauryl sulfate, and vitamin E polyethylene glycol succinate. The tablets are film-coated with a coating material containing the following inactive ingredients: carnauba wax, ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin."
},
{
"NDCCode": "0006-3075-02",
"PackageDescription": "4 DOSE PACK in 1 CARTON (0006-3075-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3075-01) ",
"NDC11Code": "00006-3075-02",
"ProductNDC": "0006-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevymis",
"NonProprietaryName": "Letermovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209939",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "LETERMOVIR",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: 1 Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). (1.1), 2 Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). (1.2).",
"Description": "PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase complex, and is administered orally or by intravenous infusion. Letermovir has a molecular formula of C29H28F4N4O4 and a molecular weight of 572.55. The chemical name for letermovir is (4S)-2-{8-Fluoro-2-[4-(3- methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5- (trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid. Letermovir is very slightly soluble in water. The chemical structure of letermovir is:. PREVYMIS is available as 240 mg and 480 mg tablets. PREVYMIS tablets contain either 240 mg or 480 mg of letermovir and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone 25, and film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. Carnauba wax is added as a polishing agent. PREVYMIS is available as 20 mg and 120 mg packets of oral pellets. PREVYMIS packets of oral pellets contain either 20 mg or 120 mg of letermovir. PREVYMIS oral pellets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone K-29/32, and are film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. PREVYMIS is also available as 240 mg/12 mL (20 mg/mL) and 480 mg/24 mL (20 mg/mL) injection for intravenous infusion. PREVYMIS injection is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial. Each 1 mL of solution contains 20 mg letermovir, hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection. The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5."
},
{
"NDCCode": "0006-3076-02",
"PackageDescription": "4 DOSE PACK in 1 CARTON (0006-3076-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3076-01) ",
"NDC11Code": "00006-3076-02",
"ProductNDC": "0006-3076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevymis",
"NonProprietaryName": "Letermovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209939",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "LETERMOVIR",
"StrengthNumber": "480",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: 1 Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). (1.1), 2 Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). (1.2).",
"Description": "PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase complex, and is administered orally or by intravenous infusion. Letermovir has a molecular formula of C29H28F4N4O4 and a molecular weight of 572.55. The chemical name for letermovir is (4S)-2-{8-Fluoro-2-[4-(3- methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5- (trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid. Letermovir is very slightly soluble in water. The chemical structure of letermovir is:. PREVYMIS is available as 240 mg and 480 mg tablets. PREVYMIS tablets contain either 240 mg or 480 mg of letermovir and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone 25, and film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. Carnauba wax is added as a polishing agent. PREVYMIS is available as 20 mg and 120 mg packets of oral pellets. PREVYMIS packets of oral pellets contain either 20 mg or 120 mg of letermovir. PREVYMIS oral pellets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone K-29/32, and are film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. PREVYMIS is also available as 240 mg/12 mL (20 mg/mL) and 480 mg/24 mL (20 mg/mL) injection for intravenous infusion. PREVYMIS injection is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial. Each 1 mL of solution contains 20 mg letermovir, hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection. The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5."
},
{
"NDCCode": "0006-3856-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01) ",
"NDC11Code": "00006-3856-02",
"ProductNDC": "0006-3856",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Recarbrio",
"NonProprietaryName": "Imipenem Anhydrous, Cilastatin, And Relebactam Anhydrous",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212819",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "IMIPENEM ANHYDROUS; CILASTATIN; RELEBACTAM ANHYDROUS",
"StrengthNumber": "500; 500; 250",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: 1 Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). (1.1), 2 Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options. (1.2), 3 Complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options. (1.3).",
"Description": "RECARBRIO (imipenem, cilastatin, and relebactam) for injection is an antibacterial combination product consisting of imipenem, a carbapenem antibacterial drug, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a diazabicyclooctane beta-lactamase inhibitor, for intravenous administration."
},
{
"NDCCode": "0006-4047-20",
"PackageDescription": "25 POUCH in 1 CARTON (0006-4047-20) / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01) ",
"NDC11Code": "00006-4047-20",
"ProductNDC": "0006-4047",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Rotateq",
"NonProprietaryName": "Rotavirus Vaccine, Live, Oral, Pentavalent",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20060203",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125122",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN",
"StrengthNumber": "2200000; 2800000; 2200000; 2000000; 2300000",
"StrengthUnit": "[iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060203",
"SamplePackage": "N",
"IndicationAndUsage": "RotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age [see Dosage and Administration (2.1)].",
"Description": "RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as type P1A[8], from the human rotavirus parent strain and the outer capsid protein of type G6 from the bovine rotavirus parent strain (see Table 7). The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents. The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives. RotaTeq, an oral solution, is a pale yellow clear liquid that may have a pink tint. RotaTeq is supplied in two presentations, an ampule presentation and a tube presentation. The ampule and the plastic tube and cap do not contain latex."
},
{
"NDCCode": "0006-4047-41",
"PackageDescription": "10 POUCH in 1 CARTON (0006-4047-41) / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01) ",
"NDC11Code": "00006-4047-41",
"ProductNDC": "0006-4047",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Rotateq",
"NonProprietaryName": "Rotavirus Vaccine, Live, Oral, Pentavalent",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20060203",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125122",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN",
"StrengthNumber": "2200000; 2800000; 2200000; 2000000; 2300000",
"StrengthUnit": "[iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060203",
"SamplePackage": "N",
"IndicationAndUsage": "RotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age [see Dosage and Administration (2.1)].",
"Description": "RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as type P1A[8], from the human rotavirus parent strain and the outer capsid protein of type G6 from the bovine rotavirus parent strain (see Table 7). The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents. The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives. RotaTeq, an oral solution, is a pale yellow clear liquid that may have a pink tint. RotaTeq is supplied in two presentations, an ampule presentation and a tube presentation. The ampule and the plastic tube and cap do not contain latex."
},
{
"NDCCode": "0006-4093-02",
"PackageDescription": "10 SYRINGE in 1 CARTON (0006-4093-02) / .5 mL in 1 SYRINGE (0006-4093-01) ",
"NDC11Code": "00006-4093-02",
"ProductNDC": "0006-4093",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Recombivax Hb",
"NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "19860723",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101066",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN",
"StrengthNumber": "5",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860723",
"SamplePackage": "N",
"IndicationAndUsage": "RECOMBIVAX HB® [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.",
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"Description": "VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques developed at the Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate. VAQTA is a sterile suspension for intramuscular injection. One milliliter of the vaccine contains approximately 50U of hepatitis A virus antigen, which is purified and formulated without a preservative. Within the limits of current assay variability, the 50U dose of VAQTA contains less than 0.1 mcg of non-viral protein, less than 4 × 10–6 mcg of DNA, less than 10–4 mcg of bovine albumin, and less than 0.8 mcg of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb), including neomycin. Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately 0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride. Each 1-mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride."
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<ProductNDC>10875-5030</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mineral</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20140626</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Calumet Karns City Refining LLC</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10875-5030-3</NDCCode>
<PackageDescription>20411.66 kg in 1 TANK (10875-5030-3)</PackageDescription>
<NDC11Code>10875-5030-03</NDC11Code>
<ProductNDC>10875-5030</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mineral</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20140626</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Calumet Karns City Refining LLC</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10875-5030-4</NDCCode>
<PackageDescription>72574.79 kg in 1 TANK (10875-5030-4)</PackageDescription>
<NDC11Code>10875-5030-04</NDC11Code>
<ProductNDC>10875-5030</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mineral</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20140626</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Calumet Karns City Refining LLC</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62670-5030-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-5030-0)</PackageDescription>
<NDC11Code>62670-5030-00</NDC11Code>
<ProductNDC>62670-5030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Mango Dragonfruit</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160217</StartMarketingDate>
<EndMarketingDate>20160817</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0006-0007-02</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0006-0007-02) > 50 kg in 1 BAG</PackageDescription>
<NDC11Code>00006-0007-02</NDC11Code>
<ProductNDC>0006-0007</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Carbidopa</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19750502</StartMarketingDate>
<MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>CARBIDOPA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0006-0277-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 DOSE PACK (0006-0277-02) </PackageDescription>
<NDC11Code>00006-0277-02</NDC11Code>
<ProductNDC>0006-0277</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Januvia</ProprietaryName>
<NonProprietaryName>Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021995</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0006-0461-02</NDCCode>
<PackageDescription>2 CAPSULE in 1 DOSE PACK (0006-0461-02) </PackageDescription>
<NDC11Code>00006-0461-02</NDC11Code>
<ProductNDC>0006-0461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emend</ProprietaryName>
<NonProprietaryName>Aprepitant</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030326</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021549</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>APREPITANT</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMEND® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).</IndicationAndUsage>
<Description>EMEND capsules contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empirical formula is C23H21F7N4O3, and its structural formula is. Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. Each capsule of EMEND for oral administration contains either 80 mg or 125 mg of aprepitant and the following inactive ingredients: sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate. The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide. The 125-mg capsule also contains red ferric oxide and yellow ferric oxide. Each pouch of EMEND for oral suspension 125 mg contains 125 mg of aprepitant and the following inactive ingredients: sucrose, lactose, hydroxypropyl cellulose, sodium lauryl sulfate, red iron oxide, and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>0006-0575-03</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (0006-0575-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0575-02) </PackageDescription>
<NDC11Code>00006-0575-03</NDC11Code>
<ProductNDC>0006-0575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Janumet</ProprietaryName>
<NonProprietaryName>Sitagliptin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070330</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022044</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070330</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>JANUMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>JANUMET (sitagliptin and metformin HCl) tablets for oral use contain two antihyperglycemic drugs: sitagliptin and metformin HCl.</Description>
</NDC>
<NDC>
<NDCCode>0006-0577-03</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (0006-0577-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0577-02) </PackageDescription>
<NDC11Code>00006-0577-03</NDC11Code>
<ProductNDC>0006-0577</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Janumet</ProprietaryName>
<NonProprietaryName>Sitagliptin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070330</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022044</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070330</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>JANUMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>JANUMET (sitagliptin and metformin HCl) tablets for oral use contain two antihyperglycemic drugs: sitagliptin and metformin HCl.</Description>
</NDC>
<NDC>
<NDCCode>0006-3026-02</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0006-3026-02) / 4 mL in 1 VIAL (0006-3026-01) </PackageDescription>
<NDC11Code>00006-3026-02</NDC11Code>
<ProductNDC>0006-3026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Keytruda</ProprietaryName>
<NonProprietaryName>Pembrolizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125514</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>PEMBROLIZUMAB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:. Melanoma: 1 for the treatment of patients with unresectable or metastatic melanoma. (1.1), 2 for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. (1.1).</IndicationAndUsage>
<Description>Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells. KEYTRUDA (pembrolizumab) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous use. Each vial contains 100 mg of pembrolizumab in 4 mL of solution. Each 1 mL of solution contains 25 mg of pembrolizumab and is formulated in: L-histidine (1.55 mg), polysorbate 80 (0.2 mg), sucrose (70 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0006-3029-02</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0006-3029-02) > 15 mL in 1 VIAL (0006-3029-01) </PackageDescription>
<NDC11Code>00006-3029-02</NDC11Code>
<ProductNDC>0006-3029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Keytruda</ProprietaryName>
<NonProprietaryName>Pembrolizumab</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140904</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125514</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>PEMBROLIZUMAB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0006-3061-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-02) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-03) </PackageDescription>
<NDC11Code>00006-3061-02</NDC11Code>
<ProductNDC>0006-3061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emend</ProprietaryName>
<NonProprietaryName>Fosaprepitant Dimeglumine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022023</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>FOSAPREPITANT DIMEGLUMINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0006-3074-02</NDCCode>
<PackageDescription>2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01) </PackageDescription>
<NDC11Code>00006-3074-02</NDC11Code>
<ProductNDC>0006-3074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zepatier</ProprietaryName>
<NonProprietaryName>Elbasvir And Grazoprevir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160128</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208261</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ELBASVIR; GRAZOPREVIR ANHYDROUS</SubstanceName>
<StrengthNumber>50; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZEPATIER® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>ZEPATIER is a fixed-dose combination tablet containing elbasvir and grazoprevir for oral administration. Elbasvir is an HCV NS5A inhibitor, and grazoprevir is an HCV NS3/4A protease inhibitor. Each tablet contains 50 mg elbasvir and 100 mg grazoprevir. The tablets include the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, sodium chloride, sodium lauryl sulfate, and vitamin E polyethylene glycol succinate. The tablets are film-coated with a coating material containing the following inactive ingredients: carnauba wax, ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0006-3075-02</NDCCode>
<PackageDescription>4 DOSE PACK in 1 CARTON (0006-3075-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3075-01) </PackageDescription>
<NDC11Code>00006-3075-02</NDC11Code>
<ProductNDC>0006-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevymis</ProprietaryName>
<NonProprietaryName>Letermovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209939</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>LETERMOVIR</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: 1 Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). (1.1), 2 Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). (1.2).</IndicationAndUsage>
<Description>PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase complex, and is administered orally or by intravenous infusion. Letermovir has a molecular formula of C29H28F4N4O4 and a molecular weight of 572.55. The chemical name for letermovir is (4S)-2-{8-Fluoro-2-[4-(3- methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5- (trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid. Letermovir is very slightly soluble in water. The chemical structure of letermovir is:. PREVYMIS is available as 240 mg and 480 mg tablets. PREVYMIS tablets contain either 240 mg or 480 mg of letermovir and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone 25, and film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. Carnauba wax is added as a polishing agent. PREVYMIS is available as 20 mg and 120 mg packets of oral pellets. PREVYMIS packets of oral pellets contain either 20 mg or 120 mg of letermovir. PREVYMIS oral pellets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone K-29/32, and are film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. PREVYMIS is also available as 240 mg/12 mL (20 mg/mL) and 480 mg/24 mL (20 mg/mL) injection for intravenous infusion. PREVYMIS injection is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial. Each 1 mL of solution contains 20 mg letermovir, hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection. The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0006-3076-02</NDCCode>
<PackageDescription>4 DOSE PACK in 1 CARTON (0006-3076-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3076-01) </PackageDescription>
<NDC11Code>00006-3076-02</NDC11Code>
<ProductNDC>0006-3076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevymis</ProprietaryName>
<NonProprietaryName>Letermovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209939</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>LETERMOVIR</SubstanceName>
<StrengthNumber>480</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: 1 Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). (1.1), 2 Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). (1.2).</IndicationAndUsage>
<Description>PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase complex, and is administered orally or by intravenous infusion. Letermovir has a molecular formula of C29H28F4N4O4 and a molecular weight of 572.55. The chemical name for letermovir is (4S)-2-{8-Fluoro-2-[4-(3- methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5- (trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid. Letermovir is very slightly soluble in water. The chemical structure of letermovir is:. PREVYMIS is available as 240 mg and 480 mg tablets. PREVYMIS tablets contain either 240 mg or 480 mg of letermovir and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone 25, and film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. Carnauba wax is added as a polishing agent. PREVYMIS is available as 20 mg and 120 mg packets of oral pellets. PREVYMIS packets of oral pellets contain either 20 mg or 120 mg of letermovir. PREVYMIS oral pellets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone K-29/32, and are film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. PREVYMIS is also available as 240 mg/12 mL (20 mg/mL) and 480 mg/24 mL (20 mg/mL) injection for intravenous infusion. PREVYMIS injection is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial. Each 1 mL of solution contains 20 mg letermovir, hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection. The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0006-3856-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01) </PackageDescription>
<NDC11Code>00006-3856-02</NDC11Code>
<ProductNDC>0006-3856</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Recarbrio</ProprietaryName>
<NonProprietaryName>Imipenem Anhydrous, Cilastatin, And Relebactam Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212819</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>IMIPENEM ANHYDROUS; CILASTATIN; RELEBACTAM ANHYDROUS</SubstanceName>
<StrengthNumber>500; 500; 250</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: 1 Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). (1.1), 2 Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options. (1.2), 3 Complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options. (1.3).</IndicationAndUsage>
<Description>RECARBRIO (imipenem, cilastatin, and relebactam) for injection is an antibacterial combination product consisting of imipenem, a carbapenem antibacterial drug, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a diazabicyclooctane beta-lactamase inhibitor, for intravenous administration.</Description>
</NDC>
<NDC>
<NDCCode>0006-4047-20</NDCCode>
<PackageDescription>25 POUCH in 1 CARTON (0006-4047-20) / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01) </PackageDescription>
<NDC11Code>00006-4047-20</NDC11Code>
<ProductNDC>0006-4047</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Rotateq</ProprietaryName>
<NonProprietaryName>Rotavirus Vaccine, Live, Oral, Pentavalent</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060203</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125122</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN</SubstanceName>
<StrengthNumber>2200000; 2800000; 2200000; 2000000; 2300000</StrengthNumber>
<StrengthUnit>[iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age [see Dosage and Administration (2.1)].</IndicationAndUsage>
<Description>RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as type P1A[8], from the human rotavirus parent strain and the outer capsid protein of type G6 from the bovine rotavirus parent strain (see Table 7). The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents. The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives. RotaTeq, an oral solution, is a pale yellow clear liquid that may have a pink tint. RotaTeq is supplied in two presentations, an ampule presentation and a tube presentation. The ampule and the plastic tube and cap do not contain latex.</Description>
</NDC>
<NDC>
<NDCCode>0006-4047-41</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (0006-4047-41) / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01) </PackageDescription>
<NDC11Code>00006-4047-41</NDC11Code>
<ProductNDC>0006-4047</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Rotateq</ProprietaryName>
<NonProprietaryName>Rotavirus Vaccine, Live, Oral, Pentavalent</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060203</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125122</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN</SubstanceName>
<StrengthNumber>2200000; 2800000; 2200000; 2000000; 2300000</StrengthNumber>
<StrengthUnit>[iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age [see Dosage and Administration (2.1)].</IndicationAndUsage>
<Description>RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as type P1A[8], from the human rotavirus parent strain and the outer capsid protein of type G6 from the bovine rotavirus parent strain (see Table 7). The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents. The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives. RotaTeq, an oral solution, is a pale yellow clear liquid that may have a pink tint. RotaTeq is supplied in two presentations, an ampule presentation and a tube presentation. The ampule and the plastic tube and cap do not contain latex.</Description>
</NDC>
<NDC>
<NDCCode>0006-4093-02</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0006-4093-02) / .5 mL in 1 SYRINGE (0006-4093-01) </PackageDescription>
<NDC11Code>00006-4093-02</NDC11Code>
<ProductNDC>0006-4093</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Recombivax Hb</ProprietaryName>
<NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19860723</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101066</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus Vaccine [EPC], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RECOMBIVAX HB® [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.</IndicationAndUsage>
<Description>RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. Each dose contains less than 1% yeast protein. The vaccine produced by the Merck Sharp & Dohme LLC, Rahway, NJ, USA method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and human). The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products. RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. [See How Supplied/Storage and Handling (16).]. Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen. Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen. Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen. All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL residual formaldehyde. The vaccine is of the adw subtype.</Description>
</NDC>
<NDC>
<NDCCode>0006-4094-02</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0006-4094-02) / 1 mL in 1 SYRINGE (0006-4094-01) </PackageDescription>
<NDC11Code>00006-4094-02</NDC11Code>
<ProductNDC>0006-4094</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Recombivax Hb</ProprietaryName>
<NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19860723</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101066</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus Vaccine [EPC], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RECOMBIVAX HB® [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.</IndicationAndUsage>
<Description>RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. Each dose contains less than 1% yeast protein. The vaccine produced by the Merck Sharp & Dohme LLC, Rahway, NJ, USA method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and human). The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products. RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. [See How Supplied/Storage and Handling (16).]. Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen. Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen. Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen. All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL residual formaldehyde. The vaccine is of the adw subtype.</Description>
</NDC>
<NDC>
<NDCCode>0006-4095-02</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0006-4095-02) / .5 mL in 1 SYRINGE (0006-4095-01) </PackageDescription>
<NDC11Code>00006-4095-02</NDC11Code>
<ProductNDC>0006-4095</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Vaqta</ProprietaryName>
<NonProprietaryName>Hepatitis A Vaccine, Inactivated</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19960329</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103606</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>[iU]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VAQTA is a vaccine indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV. (1.1).</IndicationAndUsage>
<Description>VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques developed at the Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate. VAQTA is a sterile suspension for intramuscular injection. One milliliter of the vaccine contains approximately 50U of hepatitis A virus antigen, which is purified and formulated without a preservative. Within the limits of current assay variability, the 50U dose of VAQTA contains less than 0.1 mcg of non-viral protein, less than 4 × 10–6 mcg of DNA, less than 10–4 mcg of bovine albumin, and less than 0.8 mcg of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb), including neomycin. Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately 0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride. Each 1-mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride.</Description>
</NDC>
<NDC>
<NDCCode>0006-4096-02</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0006-4096-02) / 1 mL in 1 SYRINGE (0006-4096-01) </PackageDescription>
<NDC11Code>00006-4096-02</NDC11Code>
<ProductNDC>0006-4096</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Vaqta</ProprietaryName>
<NonProprietaryName>Hepatitis A Vaccine, Inactivated</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19960329</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103606</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VAQTA is a vaccine indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV. (1.1).</IndicationAndUsage>
<Description>VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques developed at the Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate. VAQTA is a sterile suspension for intramuscular injection. One milliliter of the vaccine contains approximately 50U of hepatitis A virus antigen, which is purified and formulated without a preservative. Within the limits of current assay variability, the 50U dose of VAQTA contains less than 0.1 mcg of non-viral protein, less than 4 × 10–6 mcg of DNA, less than 10–4 mcg of bovine albumin, and less than 0.8 mcg of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb), including neomycin. Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately 0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride. Each 1-mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride.</Description>
</NDC>
</NDCList>