Sufentanil Citrate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 117693100

Effective Date

September 14, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sufentanil(50 ug in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Akorn

DUNS Number

117696832

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

NDC Product Code

17478-050

Application Number

NDA019050

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, EPIDURAL

Effective Date

March 31, 2014

Ingredients

Code: S9ZFX8403RClass: ACTIMQuantity: 50 ug in 1 mL

WaterInactive

Code: 059QF0KO0RClass: IACT