NDC 0713-0132

PROMETHEGAN

Promethazine Hydrochloride

PROMETHEGAN is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by G&w Laboratories, Inc.. The primary component is Promethazine Hydrochloride.

Product ID0713-0132_1dd4b532-7463-f8db-f082-c1430016279d
NDC0713-0132
Product TypeHuman Prescription Drug
Proprietary NamePROMETHEGAN
Generic NamePromethazine Hydrochloride
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date1987-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA087165
Labeler NameG&W Laboratories, Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0713-0132-10

1000 SUPPOSITORY in 1 BOX (0713-0132-10)
Marketing Start Date1987-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0713-0132-10 [00713013210]

PROMETHEGAN SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA087165
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-08-31

NDC 0713-0132-12 [00713013212]

PROMETHEGAN SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA087165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-08-31

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:636bb9bc-0cc5-4d6a-85be-6471acf01ffc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992478
  • 992481

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.