NDC 66887-004

Testopel

Testosterone

Testopel is a Subcutaneous Pellet in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Testosterone.

Product ID66887-004_0d89d327-599a-47fd-9cec-e9e932bacf98
NDC66887-004
Product TypeHuman Prescription Drug
Proprietary NameTestopel
Generic NameTestosterone
Dosage FormPellet
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2014-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA080911
Labeler NameEndo Pharmaceuticals, Inc.
Substance NameTESTOSTERONE
Active Ingredient Strength75 mg/1
Pharm ClassesAndrogen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 66887-004-10

10 AMPULE in 1 BOX (66887-004-10) > 1 PELLET in 1 AMPULE (66887-004-01)
Marketing Start Date2014-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66887-004-01 [66887000401]

Testopel PELLET
Marketing CategoryANDA
Application NumberANDA080911
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-31

NDC 66887-004-10 [66887000410]

Testopel PELLET
Marketing CategoryANDA
Application NumberANDA080911
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-31

NDC 66887-004-20 [66887000420]

Testopel PELLET
Marketing CategoryANDA
Application NumberANDA080911
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-31

Drug Details

Active Ingredients

IngredientStrength
TESTOSTERONE75 mg/1

OpenFDA Data

SPL SET ID:03b9c0b1-5884-11e4-8ed6-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 318240
  • 404405
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Testopel" or generic name "Testosterone"

    NDCBrand NameGeneric Name
    43773-1001TestopelTestopel
    66887-004TestopelTestopel
    0023-5990AndrodermTestosterone
    0023-5992AndrodermTestosterone
    0051-8425AndrogelTestosterone
    0051-8450AndrogelTestosterone
    0051-8462AndrogelTestosterone
    0254-1012Testosteronetestosterone
    0591-2114TestosteroneTestosterone
    0591-2363Testosteronetestosterone
    0591-2921TestosteroneTestosterone
    0591-2924TestosteroneTestosterone
    0591-2925TestosteroneTestosterone
    0591-2926TestosteroneTestosterone
    0591-3216TestosteroneTestosterone
    0245-0871VogelxoTestosterone
    0245-0872VogelxoTestosterone

    Trademark Results [Testopel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TESTOPEL
    TESTOPEL
    73132009 1089034 Live/Registered
    BARTOR PHARMACAL CO., INC.
    1977-06-27

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