NDC 0169-7708

Norditropin

Somatropin

Norditropin is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Somatropin.

Product ID0169-7708_4126dc90-ae9b-4ed4-91ba-afdd8bc24036
NDC0169-7708
Product TypeHuman Prescription Drug
Proprietary NameNorditropin
Generic NameSomatropin
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2005-01-03
Marketing CategoryNDA / NDA
Application NumberNDA021148
Labeler NameNovo Nordisk
Substance NameSOMATROPIN
Active Ingredient Strength15 mg/1.5mL
Pharm ClassesRecombinant Human Growth Hormone [EPC],Human Growth Hormone [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0169-7708-21

1 SYRINGE, PLASTIC in 1 CARTON (0169-7708-21) > 1.5 mL in 1 SYRINGE, PLASTIC
Marketing Start Date2010-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0169-7708-11 [00169770811]

Norditropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021148
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-01-03
Marketing End Date2012-11-14

NDC 0169-7708-91 [00169770891]

Norditropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021148
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-01-03
Marketing End Date2012-11-14

NDC 0169-7708-92 [00169770892]

Norditropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021148
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-01

NDC 0169-7708-21 [00169770821]

Norditropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021148
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-03-01

Drug Details

Active Ingredients

IngredientStrength
SOMATROPIN15 mg/1.5mL

OpenFDA Data

SPL SET ID:1058e17c-9261-459c-a3e6-fae38d196c14
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849850
  • 849851
  • 847348
  • 1736329
  • 1736262
  • 847243
  • 847245
  • 847247
  • Pharmacological Class

    • Recombinant Human Growth Hormone [EPC]
    • Human Growth Hormone [CS]

    NDC Crossover Matching brand name "Norditropin" or generic name "Somatropin"

    NDCBrand NameGeneric Name
    0169-7708NorditropinNorditropin
    0169-7704NorditropinNorditropin
    0169-7705NorditropinNorditropin
    0169-7703NorditropinNorditropin
    0013-2626GENOTROPINsomatropin
    0013-2646GENOTROPINsomatropin
    0013-2649GENOTROPINsomatropin
    0013-2650GENOTROPINsomatropin
    0013-2651GENOTROPINsomatropin
    0002-7335HUMATROPESomatropin
    0002-8147HUMATROPESomatropin
    0002-8148HUMATROPESomatropin
    0002-8149HUMATROPESomatropin

    Trademark Results [Norditropin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NORDITROPIN
    NORDITROPIN
    73752012 1745458 Live/Registered
    NORDISK GENTOFTE A/S
    1988-09-15

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