NDC 0591-2985

PHENADOZ

Promethazine Hydrochloride

PHENADOZ is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Promethazine Hydrochloride.

Product ID0591-2985_76b9950c-88b0-4d55-ae91-2bb47b470efa
NDC0591-2985
Product TypeHuman Prescription Drug
Proprietary NamePHENADOZ
Generic NamePromethazine Hydrochloride
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2015-03-16
Marketing CategoryANDA / ANDA
Application NumberANDA040428
Labeler NameActavis Pharma, Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength13 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0591-2985-39

12 PACKET in 1 BOX (0591-2985-39) > 1 SUPPOSITORY in 1 PACKET
Marketing Start Date2015-03-16
Marketing End Date2021-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2985-39 [00591298539]

PHENADOZ SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA040428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-16
Marketing End Date2021-02-28

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE12.5 mg/1

OpenFDA Data

SPL SET ID:e3cbbde7-2822-4d4c-bed7-36cf90df1715
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992443
  • 992441
  • 992454
  • 992456

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]

    NDC Crossover Matching brand name "PHENADOZ" or generic name "Promethazine Hydrochloride"

    NDCBrand NameGeneric Name
    0591-2985PHENADOZPromethazine Hydrochloride
    0591-2992PHENADOZPromethazine Hydrochloride
    50090-3894PHENADOZPHENADOZ
    50090-3897PHENADOZPHENADOZ
    0641-6082PHENERGANPromethazine Hydrochloride
    0641-6083PHENERGANPromethazine Hydrochloride
    0641-6084PHENERGANPromethazine Hydrochloride
    0615-1539PromethazinePromethazine Hydrochloride
    0121-0927Promethazine HydrochloridePromethazine Hydrochloride
    0404-9940PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
    0404-9941Promethazine HydrochloridePromethazine Hydrochloride
    0404-9942Promethazine HydrochloridePromethazine Hydrochloride
    0440-5195Promethazine HydrochloridePromethazine Hydrochloride
    0440-8195Promethazine HydrochloridePromethazine Hydrochloride
    0591-5307Promethazine HydrochloridePromethazine Hydrochloride
    0591-5319Promethazine HydrochloridePromethazine Hydrochloride
    0603-1584Promethazine HydrochloridePromethazine Hydrochloride
    0615-7668promethazine hydrochloridepromethazine hydrochloride
    0615-8154Promethazine HydrochloridePromethazine Hydrochloride
    0641-0928Promethazine HydrochloridePromethazine Hydrochloride
    0641-0929Promethazine HydrochloridePromethazine Hydrochloride
    0641-0948Promethazine HydrochloridePromethazine Hydrochloride
    0641-0949Promethazine HydrochloridePromethazine Hydrochloride
    0641-0955Promethazine HydrochloridePromethazine Hydrochloride
    0641-0956Promethazine HydrochloridePromethazine Hydrochloride
    0641-1495Promethazine HydrochloridePromethazine Hydrochloride
    0641-1496Promethazine HydrochloridePromethazine Hydrochloride

    Trademark Results [PHENADOZ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PHENADOZ
    PHENADOZ
    78276619 2881637 Live/Registered
    ALLERGAN SALES, LLC
    2003-07-21
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.