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Alfentanil Hydrochloride

These highlights do not include all the information needed to use ALFENTANIL HCl INJECTION safely and effectively. See full prescribing information for ALFENTANIL HCl INJECTION.ALFENTANIL HCl Injection, for Intravenous use, CII Initial U.S. Approval: 1986

Approved
Approval ID

098af6c6-7400-4b2b-bae6-03d5913ad712

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 25, 2024

Manufacturers
FDA

Akorn

DUNS: 117693100

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Alfentanil Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17478-067
Application NumberNDA019353
Product Classification
M
Marketing Category
C73594
G
Generic Name
Alfentanil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 25, 2024
FDA Product Classification

INGREDIENTS (3)

Alfentanil HydrochlorideActive
Quantity: 500 ug in 1 mL
Code: 11S92G0TIW
Classification: ACTIM
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT

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Alfentanil Hydrochloride - FDA Drug Approval Details