NDC 63323-518

Heparin Sodium

Heparin Sodium

Heparin Sodium is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Heparin Sodium.

Product ID63323-518_54a8871d-3b84-4049-90f2-d646e197a288
NDC63323-518
Product TypeHuman Prescription Drug
Proprietary NameHeparin Sodium
Generic NameHeparin Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-08-24
Marketing CategoryNDA / NDA
Application NumberNDA017029
Labeler NameFresenius Kabi USA, LLC
Substance NameHEPARIN SODIUM
Active Ingredient Strength5000 [USP'U]/100mL
Pharm ClassesAnti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63323-518-77

24 BAG in 1 CASE (63323-518-77) > 500 mL in 1 BAG (63323-518-01)
Marketing Start Date2017-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-518-01 [63323051801]

Heparin Sodium INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017029
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-06

NDC 63323-518-77 [63323051877]

Heparin Sodium INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017029
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-08-24

Drug Details

Active Ingredients

IngredientStrength
HEPARIN SODIUM5000 [USP'U]/100mL

OpenFDA Data

SPL SET ID:cb1c1e7a-c9ca-4a07-8833-e45ce436d287
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1658717
  • 1659195
  • Pharmacological Class

    • Anti-coagulant [EPC]
    • Heparin [CS]
    • Unfractionated Heparin [EPC]

    NDC Crossover Matching brand name "Heparin Sodium" or generic name "Heparin Sodium"

    NDCBrand NameGeneric Name
    0069-0043Heparin SodiumHeparin Sodium
    0069-0058Heparin SodiumHeparin Sodium
    0069-0059Heparin SodiumHeparin Sodium
    0069-0062Heparin SodiumHeparin Sodium
    0069-0137Heparin SodiumHeparin Sodium
    0264-5705Heparin SodiumHeparin Sodium
    0409-7651Heparin SodiumHeparin Sodium
    0409-7620Heparin SodiumHeparin Sodium
    0409-7650Heparin SodiumHeparin Sodium
    68083-136Heparin SodiumHeparin Sodium
    76045-108Heparin SodiumHeparin Sodium
    0641-0410Heparin SodiumHeparin Sodium
    0641-0391Heparin SodiumHeparin Sodium
    0641-0400Heparin SodiumHeparin Sodium
    0641-2460Heparin SodiumHeparin Sodium
    0641-2450Heparin SodiumHeparin Sodium
    0781-3327Heparin SodiumHeparin Sodium
    25021-403Heparin SodiumHeparin Sodium
    25021-402Heparin SodiumHeparin Sodium
    25021-400Heparin SodiumHeparin Sodium
    25021-401Heparin SodiumHeparin Sodium
    25021-404Heparin SodiumHeparin Sodium
    48433-329Heparin SodiumHeparin Sodium
    48433-330Heparin SodiumHeparin Sodium
    52533-104Heparin SodiumHeparin Sodium
    52533-125Heparin SodiumHeparin Sodium
    52533-142Heparin SodiumHeparin Sodium
    52533-148Heparin SodiumHeparin Sodium
    52533-211Heparin SodiumHeparin Sodium
    52533-096Heparin SodiumHeparin Sodium
    52533-029Heparin SodiumHeparin Sodium
    52584-540Heparin SodiumHeparin Sodium
    52533-098Heparin SodiumHeparin Sodium
    52533-215Heparin SodiumHeparin Sodium
    52533-097Heparin SodiumHeparin Sodium
    52533-100Heparin SodiumHeparin Sodium
    52533-138Heparin SodiumHeparin Sodium
    52533-106Heparin SodiumHeparin Sodium
    52533-179Heparin SodiumHeparin Sodium
    52533-216Heparin SodiumHeparin Sodium
    52584-400HEPARIN SODIUMHEPARIN SODIUM
    52584-262Heparin SodiumHeparin Sodium
    52584-402Heparin SodiumHeparin Sodium
    52584-542Heparin SodiumHeparin Sodium
    55154-4749Heparin SodiumHeparin Sodium
    55154-9354Heparin SodiumHeparin Sodium
    55154-2827Heparin SodiumHeparin Sodium
    0338-0424HEPARIN SODIUM IN SODIUM CHLORIDEHEPARIN SODIUM
    0338-0428HEPARIN SODIUM IN SODIUM CHLORIDEHEPARIN SODIUM
    0338-0431HEPARIN SODIUM IN SODIUM CHLORIDEHEPARIN SODIUM

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.