NDC 0378-8130

PRUDOXIN

Doxepin Hydrochloride

PRUDOXIN 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 ID0378-8130_dc5b7069-dc63-4393-bd87-2828328103b0
NDC0378-8130
Product TypeHuman Prescription Drug
Proprietary NamePRUDOXIN
Generic NameDoxepin Hydrochloride
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-08-01
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 0378-8130-45

1 TUBE in 1 CARTON (0378-8130-45) > 45 g in 1 TUBE
Marketing Start Date2018-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8130-45 [00378813045]

PRUDOXIN CREAM
Marketing CategoryNDA
Application NumberNDA020126
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-08-01

Drug Details

Active Ingredients

IngredientStrength
DOXEPIN HYDROCHLORIDE50 mg/g

OpenFDA Data

SPL SET ID:ca53346b-8ab3-4722-98f6-cf272706d3fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000091
  • 1000093

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-8130PRUDOXINdoxepin hydrochloride
    40076-511PRUDOXINPRUDOXIN
    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
    0378-8123Zonalondoxepin hydrochloride

    Trademark Results [PRUDOXIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRUDOXIN
    PRUDOXIN
    75906344 2483698 Live/Registered
    DELCOR ASSET CORPORATION
    2000-01-31
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