NDC 44087-0016

saizenprep

Somatropin

saizenprep is a Intramuscular; Subcutaneous Kit in the Human Prescription Drug category. It is labeled and distributed by Emd Serono, Inc.. The primary component is .

Product ID44087-0016_64751965-e0af-4687-8682-49411ebeff77
NDC44087-0016
Product TypeHuman Prescription Drug
Proprietary Namesaizenprep
Generic NameSomatropin
Dosage FormKit
Route of AdministrationINTRAMUSCULAR; SUBCUTANEOUS
Marketing Start Date2017-01-17
Marketing CategoryBLA / NDA
Application NumberBLA019764
Labeler NameEMD Serono, Inc.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 44087-0016-1

1 KIT in 1 CARTON (44087-0016-1) * 1.51 mL in 1 VIAL, GLASS * 1.51 mL in 1 CARTRIDGE
Marketing Start Date2017-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 44087-0016-1 [44087001601]

saizenprep KIT
Marketing CategoryBLA
Application NumberBLA019764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-17

Drug Details

OpenFDA Data

SPL SET ID:ab750de2-3eda-411a-924e-00c499eda39b
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 542438
  • 897044
  • 207836
  • 897042
  • 796918
  • 241975
  • NDC Crossover Matching brand name "saizenprep" or generic name "Somatropin"

    NDCBrand NameGeneric Name
    44087-0016saizenprepsaizenprep
    0013-2626GENOTROPINsomatropin
    0013-2646GENOTROPINsomatropin
    0013-2649GENOTROPINsomatropin
    0013-2650GENOTROPINsomatropin
    0013-2651GENOTROPINsomatropin
    0002-7335HUMATROPESomatropin
    0002-8147HUMATROPESomatropin
    0002-8148HUMATROPESomatropin
    0002-8149HUMATROPESomatropin

    Trademark Results [saizenprep]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SAIZENPREP
    SAIZENPREP
    86102215 5256523 Live/Registered
    Merck KGaA
    2013-10-25

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