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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

d2374b84-81c9-44f9-a4a9-1071281b2531

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 16, 2020

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

Products 3

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 Code63323-725
Application NumberANDA206223
Product Classification
M
Marketing Category
C73584
G
Generic Name
Remifentanil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 4, 2019
FDA Product Classification

INGREDIENTS (3)

REMIFENTANIL HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 5V444H5WIC
Classification: ACTIM
GLYCINEInactive
Quantity: 15 mg in 1 mL
Code: TE7660XO1C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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 4, 2019
FDA Product Classification

INGREDIENTS (3)

GLYCINEInactive
Quantity: 15 mg in 1 mL
Code: TE7660XO1C
Classification: IACT
REMIFENTANIL HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 5V444H5WIC
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Remifentanil Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-724
Application NumberANDA206223
Product Classification
M
Marketing Category
C73584
G
Generic Name
Remifentanil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 4, 2019
FDA Product Classification

INGREDIENTS (3)

HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GLYCINEInactive
Quantity: 15 mg in 1 mL
Code: TE7660XO1C
Classification: IACT
REMIFENTANIL HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 5V444H5WIC
Classification: ACTIM

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