Argatroban

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

Company

DUNS: 141588017

Effective Date

October 10, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Argatroban(100 mg in 1 mL)

Manufacturing Establishments1

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

Labeler

Hospira, Inc.

DUNS Number

918601238

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

NDC Product Code

0409-1140

Application Number

ANDA204120

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

September 15, 2019

Ingredients

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

Code: IY90U61Z3SClass: ACTIBQuantity: 100 mg in 1 mL

SORBITOLInactive

Code: 506T60A25RClass: IACT