Enalaprilat
Enalaprilat Injection, USP Rx Only
Approved
Approval ID
eabae489-e254-4987-ab90-7cda20a6f856
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
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 Code0143-9787
Application NumberANDA078687
Product Classification
M
Marketing Category
C73584
G
Generic Name
enalaprilat
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ENALAPRILAT DIHYDRATEActive
Quantity: 1.25 mg in 1 mL
Code: GV0O7ES0R3
Classification: ACTIM
enalaprilat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9786
Application NumberANDA078687
Product Classification
M
Marketing Category
C73584
G
Generic Name
enalaprilat
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ENALAPRILAT DIHYDRATEActive
Quantity: 2.5 mg in 2 mL
Code: GV0O7ES0R3
Classification: ACTIM