NDC 63187-038

promethazine hydrochloride

Promethazine Hydrochloride

promethazine hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Promethazine Hydrochloride.

Product ID63187-038_52266eb3-3fb1-4838-b2e1-bbe553ff7cf2
NDC63187-038
Product TypeHuman Prescription Drug
Proprietary Namepromethazine hydrochloride
Generic NamePromethazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-01-27
Marketing CategoryANDA / ANDA
Application NumberANDA040863
Labeler NameProficient Rx LP
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63187-038-10

10 TABLET in 1 BOTTLE (63187-038-10)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-038-12 [63187003812]

promethazine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040863
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 63187-038-10 [63187003810]

promethazine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040863
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 63187-038-30 [63187003830]

promethazine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040863
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 63187-038-60 [63187003860]

promethazine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040863
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 63187-038-90 [63187003890]

promethazine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040863
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 63187-038-20 [63187003820]

promethazine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040863
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 63187-038-15 [63187003815]

promethazine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040863
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:9910dd1f-297f-48e6-9a0a-30cd978bb90d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992447

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]

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

    NDCBrand NameGeneric Name
    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
    68001-161Promethazine HydrochloridePromethazine Hydrochloride
    68001-162Promethazine HydrochloridePromethazine Hydrochloride
    68001-163Promethazine HydrochloridePromethazine Hydrochloride
    68071-1767Promethazine HydrochloridePromethazine Hydrochloride
    68071-3095Promethazine HydrochloridePromethazine Hydrochloride
    68071-3233Promethazine HydrochloridePromethazine Hydrochloride
    68071-3254Promethazine HydrochloridePromethazine Hydrochloride
    68071-3129Promethazine HydrochloridePromethazine Hydrochloride
    68071-4137Promethazine HydrochloridePromethazine Hydrochloride
    68071-4544Promethazine HydrochloridePromethazine Hydrochloride
    68071-4737PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
    68071-4686PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
    68071-4424PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
    68084-154Promethazine HydrochloridePromethazine Hydrochloride
    68071-4514Promethazine HydrochloridePromethazine Hydrochloride
    68084-155Promethazine HydrochloridePromethazine Hydrochloride
    68071-4809Promethazine HydrochloridePromethazine Hydrochloride
    68151-0146PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
    68151-1584Promethazine HydrochloridePromethazine Hydrochloride
    68258-3011Promethazine HydrochloridePromethazine Hydrochloride
    68382-042Promethazine HydrochloridePromethazine Hydrochloride
    68382-041Promethazine HydrochloridePromethazine Hydrochloride
    68258-3028Promethazine HydrochloridePromethazine Hydrochloride
    68382-040Promethazine HydrochloridePromethazine Hydrochloride
    68788-7028Promethazine HydrochloridePromethazine Hydrochloride
    68788-7287Promethazine HydrochloridePromethazine Hydrochloride
    68788-9270Promethazine HydrochloridePromethazine Hydrochloride
    70518-0141Promethazine HydrochloridePromethazine Hydrochloride
    70518-0165Promethazine HydrochloridePromethazine Hydrochloride
    70408-146PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
    70518-0250Promethazine HydrochloridePromethazine Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.