Anticoagulant Sodium Citrate

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

Company

DUNS: 942344649

Effective Date

January 10, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Manufacturing Establishments1

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

Labeler

CSL Plasma Inc.

DUNS Number

942344649

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

NDC Product Code

81839-782

Application Number

BA125750

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

May 5, 2022

Ingredients

WaterInactive

Code: 059QF0KO0RClass: IACT

Citric Acid monohydrateInactive

Code: 2968PHW8QPClass: IACT

Code: B22547B95KClass: ACTIMQuantity: 40 mg in 1 mL