Arixtra

Basic Information

Product Name

Arixtra

FDA Product Code

67457-592

Regulatory Information

NDC Product Code

67457-592

Application Number

NDA021345

Marketing Category

C73594

Effective Date

June 8, 2020

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ARIXTRA safely and effectively. See full prescribing information for ARIXTRA. ARIXTRA (fondaparinux sodium injection), for subcutaneous useInitial U.S. Approval: 2001

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

FONDAPARINUX SODIUM

Quantity: 2.5 mg in 0.5 mL

Code: X0Q6N9USOZ

Class Code: ACTIB

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: CNTM

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: CNTM

Active Moieties

FONDAPARINUX

Code: J177FOW5JL