NDC 21695-959

Promethegan

Promethazine Hydrochloride

Promethegan is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Promethazine Hydrochloride.

Product ID21695-959_c809171c-d424-4a17-a98d-f280a892b410
NDC21695-959
Product TypeHuman Prescription Drug
Proprietary NamePromethegan
Generic NamePromethazine Hydrochloride
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2002-02-05
Marketing CategoryANDA / ANDA
Application NumberANDA040428
Labeler NameRebel Distributors Corp
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-959-12

12 SUPPOSITORY in 1 BOX (21695-959-12)
Marketing Start Date2002-02-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-959-12 [21695095912]

Promethegan SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA040428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-02-05
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:c809171c-d424-4a17-a98d-f280a892b410
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992459
  • 992454

    • 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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