NDC 0603-1584

Promethazine Hydrochloride

Promethazine Hydrochloride

Promethazine Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Promethazine Hydrochloride.

Product ID0603-1584_153678e2-0b91-4267-a9b9-e0a9913a98a3
NDC0603-1584
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride
Generic NamePromethazine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2006-04-26
Marketing End Date2021-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA040643
Labeler NamePar Pharmaceutical
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength6 mg/5mL
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN

Packaging

NDC 0603-1584-54

118 mL in 1 BOTTLE (0603-1584-54)
Marketing Start Date2006-04-26
Marketing End Date2021-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-1584-56 [00603158456]

Promethazine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA040643
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-04-26
Marketing End Date2017-04-10

NDC 0603-1584-58 [00603158458]

Promethazine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA040643
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-04-26
Marketing End Date2021-05-31

NDC 0603-1584-54 [00603158454]

Promethazine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA040643
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-04-26
Marketing End Date2021-04-30

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:fa5cd572-8c5c-4097-b5e2-1fcc69aee315
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992432
    • UPC Code
  • 0306031584589

    • 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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