Remifentanil Hydrochloride
These highlights do not include all the information needed to use REMIFENTANIL HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for REMIFENTANIL HYDROCHLORIDE FOR INJECTION. REMIFENTANIL HYDROCHLORIDE for injection, for intravenous use, CII Initial U.S. Approval: 1996
Approved
Approval ID
5b8025d2-3424-477b-9cff-3990a98c2a65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2021
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Remifentanil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-723
Application NumberANDA206223
Product Classification
M
Marketing Category
C73584
G
Generic Name
Remifentanil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 31, 2019
FDA Product Classification
INGREDIENTS (3)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
REMIFENTANIL HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 5V444H5WIC
Classification: ACTIM
GLYCINEInactive
Quantity: 15 mg in 1 mL
Code: TE7660XO1C
Classification: IACT