etomidate
Etomidate Injection, USPFor Intravenous Use
Approved
Approval ID
8b71a0a4-d3e7-49a9-b40e-976c94f2eb6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 1
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 Code68382-545
Application NumberANDA202360
Product Classification
M
Marketing Category
C73584
G
Generic Name
etomidate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 14, 2022
FDA Product Classification
INGREDIENTS (2)
ETOMIDATEActive
Quantity: 2 mg in 1 mL
Code: Z22628B598
Classification: ACTIB
PROPYLENE GLYCOLInactive
Quantity: 0.35 mL in 1 mL
Code: 6DC9Q167V3
Classification: IACT