NDC 43063-708

Promethazine

Promethazine Hydrochloride

Promethazine 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 ID43063-708_800fb019-6c33-71d7-e053-2a91aa0a3ab0
NDC43063-708
Product TypeHuman Prescription Drug
Proprietary NamePromethazine
Generic NamePromethazine Hydrochloride
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2015-02-17
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 Through2020-12-31

Packaging

NDC 43063-708-02

2 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-708-02)
Marketing Start Date2016-09-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-708-02 [43063070802]

Promethazine SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA040428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-22

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:cd947c48-0d50-4fd8-95b7-2c238ce12761
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992454
    • UPC Code
  • 0343063708026

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]
    • Phenothiazine [EPC]
    • Phenothiazines [CS]

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

    NDCBrand NameGeneric Name
    0615-1539PromethazinePromethazine Hydrochloride
    43063-708PromethazinePromethazine
    54348-117PromethazinePromethazine
    0591-2985PHENADOZPromethazine Hydrochloride
    0591-2992PHENADOZPromethazine Hydrochloride
    0641-6082PHENERGANPromethazine Hydrochloride
    0641-6083PHENERGANPromethazine Hydrochloride
    0641-6084PHENERGANPromethazine 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
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