NDC 55289-928

PROMETHEGAN

Promethazine Hydrochloride

PROMETHEGAN is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Promethazine Hydrochloride.

Product ID55289-928_7a043bee-f429-1032-e053-2991aa0a8536
NDC55289-928
Product TypeHuman Prescription Drug
Proprietary NamePROMETHEGAN
Generic NamePromethazine Hydrochloride
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2002-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA040428
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55289-928-02

2 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-02)
Marketing Start Date2011-07-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-928-79 [55289092879]

PROMETHEGAN SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA040428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-13

NDC 55289-928-04 [55289092804]

PROMETHEGAN SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA040428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-13

NDC 55289-928-02 [55289092802]

PROMETHEGAN SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA040428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-13

NDC 55289-928-06 [55289092806]

PROMETHEGAN SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA040428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-13

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992454
    • UPC Code
  • 0355289928799

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]

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

    NDCBrand NameGeneric Name
    0713-0132PROMETHEGANPROMETHEGAN
    0713-0526PROMETHEGANPROMETHEGAN
    0713-0536PROMETHEGANPROMETHEGAN
    21695-959PrometheganPromethegan
    50090-1575PROMETHEGANPROMETHEGAN
    52959-731PROMETHEGANPROMETHEGAN
    55289-928PROMETHEGANPROMETHEGAN
    0591-2985PHENADOZPromethazine Hydrochloride
    0591-2992PHENADOZPromethazine Hydrochloride
    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 [PROMETHEGAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROMETHEGAN
    PROMETHEGAN
    97461296 not registered Live/Pending
    Cosette Pharmaceuticals, Inc.
    2022-06-16
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