NDC 0378-8123

Zonalon

Doxepin Hydrochloride

Zonalon is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Doxepin Hydrochloride.

Product ID0378-8123_d08db934-a9ce-4b1a-9ca1-5c6705b227a1
NDC0378-8123
Product TypeHuman Prescription Drug
Proprietary NameZonalon
Generic NameDoxepin Hydrochloride
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-11-14
Marketing CategoryNDA / NDA
Application NumberNDA020126
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDOXEPIN HYDROCHLORIDE
Active Ingredient Strength50 mg/g
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-8123-30

1 TUBE in 1 CARTON (0378-8123-30) > 30 g in 1 TUBE
Marketing Start Date2018-11-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8123-45 [00378812345]

Zonalon CREAM
Marketing CategoryNDA
Application NumberNDA020126
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-11-14

NDC 0378-8123-30 [00378812330]

Zonalon CREAM
Marketing CategoryNDA
Application NumberNDA020126
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-11-26

Drug Details

Active Ingredients

IngredientStrength
DOXEPIN HYDROCHLORIDE50 mg/g

OpenFDA Data

SPL SET ID:5f302247-525e-4acc-852b-00eb1d79af4b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000091
  • 1000095

    • Pharmacological Class

    • Tricyclic Antidepressant [EPC]
    • Tricyclic Antidepressant [EPC]

    NDC Crossover Matching brand name "Zonalon" or generic name "Doxepin Hydrochloride"

    NDCBrand NameGeneric Name
    0378-8123Zonalondoxepin hydrochloride
    40076-715ZonalonZonalon
    0378-1049Doxepin Hydrochloridedoxepin hydrochloride
    0378-3125Doxepin Hydrochloridedoxepin hydrochloride
    0378-4250Doxepin Hydrochloridedoxepin hydrochloride
    0378-4810Doxepin HydrochlorideDoxepin Hydrochloride
    0378-4811Doxepin HydrochlorideDoxepin Hydrochloride
    0378-5375Doxepin Hydrochloridedoxepin hydrochloride
    0378-5390Doxepin Hydrochloridedoxepin hydrochloride
    0378-5391Doxepin Hydrochloridedoxepin hydrochloride
    0378-6410Doxepin Hydrochloridedoxepin hydrochloride
    0378-8117Doxepin HydrochlorideDoxepin Hydrochloride
    0527-4062Doxepin HydrochlorideDoxepin Hydrochloride
    0527-4063Doxepin HydrochlorideDoxepin Hydrochloride
    0527-4064Doxepin HydrochlorideDoxepin Hydrochloride
    0527-4065Doxepin HydrochlorideDoxepin Hydrochloride
    0527-4066Doxepin HydrochlorideDoxepin Hydrochloride
    0904-6970Doxepin HydrochlorideDoxepin Hydrochloride
    0904-6971Doxepin HydrochlorideDoxepin Hydrochloride
    0904-6972Doxepin HydrochlorideDoxepin Hydrochloride
    0378-8130PRUDOXINdoxepin hydrochloride

    Trademark Results [Zonalon]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZONALON
    ZONALON
    78076391 2893077 Live/Registered
    DELCOR ASSET CORPORATION
    2001-07-30
    ZONALON
    ZONALON
    74197119 1864160 Dead/Cancelled
    GenDerm Corporation
    1991-08-22
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