NDC 12634-418

Promethazine Hydrochloride

Promethazine Hydrochloride

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

Product ID12634-418_ca133ae3-6acb-4d3e-82e0-4946943b7440
NDC12634-418
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride
Generic NamePromethazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1999-06-10
Marketing CategoryANDA / ANDA
Application NumberANDA091179
Labeler NameApotheca, Inc
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 12634-418-40

40 TABLET in 1 BOTTLE (12634-418-40)
Marketing Start Date1999-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-418-82 [12634041882]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-95 [12634041895]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-96 [12634041896]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-52 [12634041852]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-65 [12634041865]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-94 [12634041894]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-80 [12634041880]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-00 [12634041800]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-74 [12634041874]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-92 [12634041892]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-71 [12634041871]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-66 [12634041866]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-61 [12634041861]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-01 [12634041801]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-40 [12634041840]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-60 [12634041860]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-85 [12634041885]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-91 [12634041891]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

NDC 12634-418-99 [12634041899]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA091179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-10
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:89d648db-dadc-436d-8a4d-d1637ea0e6a5
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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