Etomidate
Approved
Approval ID
d07efb9e-5264-461d-96d8-e11fa71c5751
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
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 Code65219-447
Application NumberANDA215028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etomidate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 14, 2021
FDA Product Classification
INGREDIENTS (3)
ETOMIDATEActive
Quantity: 2 mg in 1 mL
Code: Z22628B598
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Etomidate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-445
Application NumberANDA215028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etomidate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 14, 2021
FDA Product Classification
INGREDIENTS (3)
ETOMIDATEActive
Quantity: 2 mg in 1 mL
Code: Z22628B598
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT