NDC 0069-0232

Fragmin

Dalteparin Sodium

Fragmin is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Dalteparin Sodium.

Product ID0069-0232_16bbab6a-76a5-4a0f-b68c-deacd61a8ab4
NDC0069-0232
Product TypeHuman Prescription Drug
Proprietary NameFragmin
Generic NameDalteparin Sodium
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2015-04-01
Marketing CategoryNDA / NDA
Application NumberNDA020287
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameDALTEPARIN SODIUM
Active Ingredient Strength25000 [iU]/mL
Pharm ClassesAnti-coagulant [EPC],Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0069-0232-01

1 VIAL, MULTI-DOSE in 1 CARTON (0069-0232-01) > 3.8 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2015-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-0232-01 [00069023201]

Fragmin INJECTION
Marketing CategoryNDA
Application NumberNDA020287
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-04-01

Drug Details

Active Ingredients

IngredientStrength
DALTEPARIN SODIUM25000 [iU]/mL

OpenFDA Data

SPL SET ID:23527b8b-9b28-4e6d-9751-33b143975ac7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 978741
  • 978755
  • 978733
  • 978735
  • 978736
  • 978737
  • 978727
  • 978740
  • 978725
  • 978745
  • 978744
  • 978747
  • 978746
  • 978778
  • 978777
  • 978757
  • Pharmacological Class

    • Anti-coagulant [EPC]
    • Heparin
    • Low-Molecular-Weight [CS]
    • Low Molecular Weight Heparin [EPC]

    NDC Crossover Matching brand name "Fragmin" or generic name "Dalteparin Sodium"

    NDCBrand NameGeneric Name
    0069-0195FragminDalteparin Sodium
    0069-0196FragminDalteparin Sodium
    0069-0206FragminDalteparin Sodium
    0069-0217FragminDalteparin Sodium
    0069-0220FragminDalteparin Sodium
    0069-0223FragminFragmin
    0069-0228FragminFragmin
    0069-0232FragminFragmin

    Trademark Results [Fragmin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FRAGMIN
    FRAGMIN
    74589650 2009395 Live/Registered
    PFIZER HEALTH AB
    1994-10-24
    FRAGMIN
    FRAGMIN
    74292024 1973843 Live/Registered
    PFIZER HEALTH AB
    1992-07-08
    FRAGMIN
    FRAGMIN
    73577765 1410088 Dead/Cancelled
    KABIVITRUM AB
    1986-01-14

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