NDC 0781-4004

Omnitrope

Somatropin

Omnitrope is a Kit in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is .

Product ID0781-4004_0684f2d9-9697-4134-aa35-ec180bdd790c
NDC0781-4004
Product TypeHuman Prescription Drug
Proprietary NameOmnitrope
Generic NameSomatropin
Dosage FormKit
Marketing Start Date2006-05-30
Marketing CategoryNDA / NDA
Application NumberNDA021426
Labeler NameSandoz Inc
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-4004-36

1 KIT in 1 CARTON (0781-4004-36) * 1 mL in 1 VIAL (0781-4014-71) * 1.14 mL in 1 VIAL (0781-4024-72)
Marketing Start Date2006-05-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-4004-36 [00781400436]

Omnitrope KIT
Marketing CategoryBLA
Application NumberBLA021426
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-05-30

Drug Details

OpenFDA Data

SPL SET ID:58d84ffa-4056-4e36-ad67-7bd4aef444a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854302
  • 864110
  • 241975
  • 645884
  • 1736267
  • 1736337
  • NDC Crossover Matching brand name "Omnitrope" or generic name "Somatropin"

    NDCBrand NameGeneric Name
    0781-3004OmnitropeOmnitrope
    0781-3001OmnitropeOmnitrope
    0781-4004OmnitropeOmnitrope
    0013-2626GENOTROPINsomatropin
    0013-2646GENOTROPINsomatropin
    0013-2649GENOTROPINsomatropin
    0013-2650GENOTROPINsomatropin
    0013-2651GENOTROPINsomatropin
    0002-7335HUMATROPESomatropin
    0002-8147HUMATROPESomatropin
    0002-8148HUMATROPESomatropin
    0002-8149HUMATROPESomatropin

    Trademark Results [Omnitrope]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OMNITROPE
    OMNITROPE
    78906838 3357908 Live/Registered
    Novartis AG
    2006-06-13
    OMNITROPE
    OMNITROPE
    78185633 not registered Dead/Abandoned
    Novartis AG
    2002-11-15

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