NDC 52959-534

Promethazine Hydrochloride

Promethazine Hydrochloride

Promethazine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Promethazine Hydrochloride.

Product ID52959-534_d6d3bcd7-acb0-47a0-a19c-33be09363bb3
NDC52959-534
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride
Generic NamePromethazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-12-14
Marketing CategoryANDA / ANDA
Application NumberANDA040596
Labeler NameH.J. Harkins Company, Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-534-12

12 TABLET in 1 BOTTLE (52959-534-12)
Marketing Start Date2005-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-534-24 [52959053424]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-28 [52959053428]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-00 [52959053400]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-45 [52959053445]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-90 [52959053490]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-01 [52959053401]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-20 [52959053420]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-10 [52959053410]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-02 [52959053402]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-60 [52959053460]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-15 [52959053415]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-12 [52959053412]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

NDC 52959-534-30 [52959053430]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-14
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:01b3a05f-6002-4cf9-96ac-ff0eed8a196c
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
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