METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
These highlights do not include all the information needed to use METOPROLOL TARTRATE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for METOPROLOL TARTRATE and HYDROCHLOROTHIAZIDE TABLETSMETOPROLOL TARTRATE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1984
Approved
Approval ID
8b78d7ad-22a8-4a9f-afb5-d18f0a4e6d36
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2025
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
metoprolol tartrate and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-301
Application NumberANDA215789
Product Classification
M
Marketing Category
C73584
G
Generic Name
metoprolol tartrate and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2025
FDA Product Classification
INGREDIENTS (9)
METOPROLOL TARTRATEActive
Quantity: 50 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
metoprolol tartrate and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-302
Application NumberANDA215789
Product Classification
M
Marketing Category
C73584
G
Generic Name
metoprolol tartrate and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2025
FDA Product Classification
INGREDIENTS (9)
METOPROLOL TARTRATEActive
Quantity: 100 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT