NDC 0143-9750

TESTOSTERONE ENANTHATE

Testosterone Enanthate

TESTOSTERONE ENANTHATE is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Testosterone Enanthate.

Product ID0143-9750_d56a5e5d-c88f-4f0d-84b4-1be06ca6ebba
NDC0143-9750
Product TypeHuman Prescription Drug
Proprietary NameTESTOSTERONE ENANTHATE
Generic NameTestosterone Enanthate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2012-09-18
Marketing CategoryANDA / ANDA
Application NumberANDA091120
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameTESTOSTERONE ENANTHATE
Active Ingredient Strength200 mg/mL
Pharm ClassesAndrogen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0143-9750-01

5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01)
Marketing Start Date2012-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9750-01 [00143975001]

TESTOSTERONE ENANTHATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA091120
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-09-18

Drug Details

Active Ingredients

IngredientStrength
TESTOSTERONE ENANTHATE200 mg/mL

OpenFDA Data

SPL SET ID:e89d6458-428c-4256-97a3-f1fa851293c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835809
  • Pharmacological Class

    • Androgen [EPC]
    • Androgen Receptor Agonists [MoA]
    • Androstanes [CS]
    • Androgen [EPC]
    • Androgen Receptor Agonists [MoA]
    • Androstanes [CS]

    NDC Crossover Matching brand name "TESTOSTERONE ENANTHATE" or generic name "Testosterone Enanthate"

    NDCBrand NameGeneric Name
    0143-9750TESTOSTERONE ENANTHATETESTOSTERONE ENANTHATE
    0591-3221Testosterone EnanthateTestosterone Enanthate
    54436-200XYOSTEDtestosterone enanthate
    54436-250XYOSTEDtestosterone enanthate
    54436-275XYOSTEDtestosterone enanthate

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