NDC 21695-112

Androgel

Testosterone

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

Product ID21695-112_77215d87-ad22-4169-bd5f-a453f10b21ef
NDC21695-112
Product TypeHuman Prescription Drug
Proprietary NameAndrogel
Generic NameTestosterone
Dosage FormGel
Route of AdministrationTRANSDERMAL
Marketing Start Date2003-06-05
Marketing CategoryNDA / NDA
Application NumberNDA021015
Labeler NameRebel Distributors Corp.
Substance NameTESTOSTERONE
Active Ingredient Strength10 mg/g
Pharm ClassesAndrogen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA ScheduleCIII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-112-30

30 PACKET in 1 CARTON (21695-112-30) > 5 g in 1 PACKET
Marketing Start Date2003-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-112-30 [21695011230]

Androgel GEL
Marketing CategoryNDA
Application NumberNDA021015
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2003-06-05
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
TESTOSTERONE10 mg/g

OpenFDA Data

SPL SET ID:77215d87-ad22-4169-bd5f-a453f10b21ef
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1597130
  • 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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