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Heparin Sodium in Sodium Chloride

These highlights do not include all the information needed to use HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION. HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION , for intravenous use Initial U.S. Approval:

Approved
Approval ID

a3041c04-0ea8-4d36-81ce-c5091c906316

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 15, 2023

Manufacturers
FDA

B. Braun Medical Inc.

DUNS: 002397347

Products 1

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

Heparin Sodium in Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0264-9872
Application NumberNDA019953
Product Classification
M
Marketing Category
C73594
G
Generic Name
Heparin Sodium in Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 15, 2023
FDA Product Classification

INGREDIENTS (5)

SODIUM PHOSPHATE, DIBASICInactive
Quantity: 0.43 g in 100 mL
Code: GR686LBA74
Classification: IACT
HEPARIN SODIUMActive
Quantity: 200 [USP'U] in 100 mL
Code: ZZ45AB24CA
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.9 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.037 g in 100 mL
Code: XF417D3PSL
Classification: IACT

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Heparin Sodium in Sodium Chloride - FDA Drug Approval Details