NDC 0051-8450

Androgel

Testosterone

Androgel is a Transdermal Gel in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Testosterone.

Product ID0051-8450_2e54dd8d-cf81-4c69-ad15-fa24f47dd3da
NDC0051-8450
Product TypeHuman Prescription Drug
Proprietary NameAndrogel
Generic NameTestosterone
Dosage FormGel
Route of AdministrationTRANSDERMAL
Marketing Start Date2011-03-14
Marketing End Date2022-08-31
Marketing CategoryNDA / NDA
Application NumberNDA021015
Labeler NameAbbVie Inc.
Substance NameTESTOSTERONE
Active Ingredient Strength10 mg/g
Pharm ClassesAndrogen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA ScheduleCIII
NDC Exclude FlagN

Packaging

NDC 0051-8450-30

30 PACKET in 1 CARTON (0051-8450-30) > 5 g in 1 PACKET (0051-8450-01)
Marketing Start Date2011-03-14
Marketing End Date2022-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0051-8450-01 [00051845001]

Androgel GEL
Marketing CategoryNDA
Application NumberNDA021015
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2011-06-02

NDC 0051-8450-30 [00051845030]

Androgel GEL
Marketing CategoryNDA
Application NumberNDA021015
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2011-03-14

Drug Details

Active Ingredients

IngredientStrength
TESTOSTERONE10 mg/g

OpenFDA Data

SPL SET ID:c506aaa3-04f8-4eb1-8dc4-e964cdd08e7f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1597130
  • 1597074
  • 1597124
  • 1597123
  • 1596780
  • 1597129
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0051-8425AndrogelTestosterone
    0051-8450AndrogelTestosterone
    0051-8462AndrogelTestosterone
    21695-112AndrogelAndrogel
    50090-1306AndrogelAndrogel
    0023-5990AndrodermTestosterone
    0023-5992AndrodermTestosterone
    0254-1012Testosteronetestosterone
    0591-2114TestosteroneTestosterone
    0591-2363Testosteronetestosterone
    0591-2921TestosteroneTestosterone
    0591-2924TestosteroneTestosterone
    0591-2925TestosteroneTestosterone
    0591-2926TestosteroneTestosterone
    0591-3216TestosteroneTestosterone
    0245-0871VogelxoTestosterone
    0245-0872VogelxoTestosterone

    Trademark Results [Androgel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ANDROGEL
    ANDROGEL
    75484512 not registered Dead/Abandoned
    EICKENBERG, HANS-UDO
    1998-05-13
    ANDROGEL
    ANDROGEL
    74721663 2232508 Live/Registered
    Unimed Pharmaceuticals, LLC
    1995-08-28
    ANDROGEL
    ANDROGEL
    73560566 not registered Dead/Abandoned
    LABORATOIRES BESINS ISCOVESCO
    1985-09-27

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