NDC 67457-603

Heparin Sodium

Heparin Sodium

Heparin Sodium is a Intravenous; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Heparin Sodium.

Product ID67457-603_0a3bd3ef-b106-43a5-9ff6-8a1aa531b0b3
NDC67457-603
Product TypeHuman Prescription Drug
Proprietary NameHeparin Sodium
Generic NameHeparin Sodium
Dosage FormInjection
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-06-14
Marketing CategoryANDA / ANDA
Application NumberANDA203851
Labeler NameMylan Institutional LLC
Substance NameHEPARIN SODIUM
Active Ingredient Strength10000 [USP'U]/mL
Pharm ClassesAnti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-603-99

25 VIAL, MULTI-DOSE in 1 CARTON (67457-603-99) > 4 mL in 1 VIAL, MULTI-DOSE (67457-603-05)
Marketing Start Date2018-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-603-05 [67457060305]

Heparin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA203851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-14

NDC 67457-603-99 [67457060399]

Heparin Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA203851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-14

Drug Details

Active Ingredients

IngredientStrength
HEPARIN SODIUM10000 [USP'U]/mL

OpenFDA Data

SPL SET ID:88114716-5759-4bc9-8a85-d28da12962cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1361226
  • 1361615
  • 1362831
  • 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.