AMIDATE(TM) ETOMIDATE
AMIDATE(TM) ETOMIDATE INJECTION, USP 20mg/10mL (2mg/mL) 10mL VIAL
Approved
Approval ID
a227d2f1-3eef-4ac6-e053-2995a90a5340
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2023
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
AMIDATE(TM) ETOMIDATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1459
Application NumberNDA018227
Product Classification
M
Marketing Category
C73594
G
Generic Name
AMIDATE(TM) ETOMIDATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (3)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ETOMIDATEActive
Quantity: 2 mg in 1 mL
Code: Z22628B598
Classification: ACTIB