Etomidate
Etomidate Injection, USP
Approved
Approval ID
75bf0494-7cb9-4e8a-8edd-af62f035d236
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
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.
Etomidate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9507
Application NumberANDA202354
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etomidate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (2)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ETOMIDATEActive
Quantity: 2 mg in 1 mL
Code: Z22628B598
Classification: ACTIB
Etomidate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9506
Application NumberANDA202354
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etomidate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (2)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ETOMIDATEActive
Quantity: 2 mg in 1 mL
Code: Z22628B598
Classification: ACTIB