ARGATROBAN

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

Company

DUNS: 604222237

Effective Date

November 7, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Argatroban(1 mg in 1 mL)

Manufacturing Establishments1

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

Labeler

Accord Healthcare Inc.

DUNS Number

725927649

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

NDC Product Code

16729-430

Application Number

NDA212035

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

November 7, 2022

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL

SORBITOLInactive

Code: 506T60A25RClass: IACTQuantity: 3 mg in 1 mL

Code: IY90U61Z3SClass: ACTIBQuantity: 1 mg in 1 mL