Enalaprilat
Enalaprilat Injection USP
Approved
Approval ID
5d398da1-020c-ccb1-a775-ce8e0b29d621
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 20, 2023
Manufacturers
FDA
Dr. Reddys Laboratories Inc
DUNS: 802315887
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
enalaprilat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-169
Application NumberANDA075578
Product Classification
M
Marketing Category
C73584
G
Generic Name
enalaprilat
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ENALAPRILATActive
Quantity: 2.5 mg in 2 mL
Code: GV0O7ES0R3
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
enalaprilat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-078
Application NumberANDA075578
Product Classification
M
Marketing Category
C73584
G
Generic Name
enalaprilat
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ENALAPRILATActive
Quantity: 1.25 mg in 1 mL
Code: GV0O7ES0R3
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT