ENALAPRIL MALEATE
ENALAPRIL MALEATE TABLETS, USP
Approved
Approval ID
d41d6d19-086c-4e17-814c-6fd6f3e81e24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2021
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-923
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (6)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 2.5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-926
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 20 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-924
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-925
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB