NDC 33261-131

Promethazine Hydrochloride

Promethazine Hydrochloride

Promethazine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Promethazine Hydrochloride.

Product ID33261-131_e06b299b-b1b6-40db-94b3-30d476196771
NDC33261-131
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride
Generic NamePromethazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-07-17
Marketing CategoryANDA / ANDA
Application NumberANDA040712
Labeler NameAidarex Pharmaceuticals LLC
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 33261-131-40

40 TABLET in 1 BOTTLE, PLASTIC (33261-131-40)
Marketing Start Date2012-07-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-131-20 [33261013120]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-17
Inactivation Date2020-01-31

NDC 33261-131-16 [33261013116]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-17
Inactivation Date2020-01-31

NDC 33261-131-40 [33261013140]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-17
Inactivation Date2020-01-31

NDC 33261-131-10 [33261013110]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-17
Inactivation Date2020-01-31

NDC 33261-131-60 [33261013160]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-17
Inactivation Date2020-01-31

NDC 33261-131-30 [33261013130]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-17
Inactivation Date2020-01-31

NDC 33261-131-90 [33261013190]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-17
Inactivation Date2020-01-31

NDC 33261-131-12 [33261013112]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-17
Inactivation Date2020-01-31

NDC 33261-131-15 [33261013115]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:857dd0a8-3e23-423c-9b5e-9a8779b4c7d0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992447
  • 992438

    • 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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