Heparin Sodium in Dextrose

Basic Information

Product Name

FDA Product Code

50090-4537

Regulatory Information

NDC Product Code

50090-4537

Application Number

NDA019952

Marketing Category

C73594

Effective Date

July 27, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use HEPARIN SODIUM IN 5% DEXTROSE INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM IN 5% DEXTROSE INJECTION. HEPARIN SODIUM IN 5% DEXTROSE INJECTION, for intravenous use Initial U.S. Approval:

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

WATER

Code: 059QF0KO0R

Class Code: IACT

HEPARIN SODIUM

Quantity: 5000 [USP'U] in 100 mL

Code: ZZ45AB24CA

Class Code: ACTIM

DEXTROSE MONOHYDRATE

Quantity: 5 g in 100 mL

Code: LX22YL083G

Class Code: ACTIB

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM

Quantity: 0.41 g in 100 mL

Code: GR686LBA74

Class Code: IACT

ANHYDROUS CITRIC ACID

Quantity: 0.093 g in 100 mL

Code: XF417D3PSL

Class Code: IACT

SODIUM METABISULFITE

Quantity: 0.07 g in 100 mL

Code: 4VON5FNS3C

Class Code: IACT

Active Moieties

HEPARIN

Code: T2410KM04A

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM

ANHYDROUS CITRIC ACID

SODIUM METABISULFITE

Active Moieties

HEPARIN

ANHYDROUS DEXTROSE