ETOMIDATE
Etomidate Injection, USP For Intravenous Use
Approved
Approval ID
0820f15a-046b-4185-a2b3-2e4051ee3d82
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
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 Code55150-222
Application NumberANDA206126
Product Classification
M
Marketing Category
C73584
G
Generic Name
ETOMIDATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (3)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ETOMIDATEActive
Quantity: 40 mg in 20 mL
Code: Z22628B598
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ETOMIDATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-221
Application NumberANDA206126
Product Classification
M
Marketing Category
C73584
G
Generic Name
ETOMIDATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (3)
ETOMIDATEActive
Quantity: 20 mg in 10 mL
Code: Z22628B598
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT