NDC 65162-678

Promethazine Hydrochloride

Promethazine

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

Product ID65162-678_1ae84957-38d1-47c2-a0bb-862a1f9fbdaf
NDC65162-678
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride
Generic NamePromethazine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2009-12-30
Marketing CategoryANDA / ANDA
Application NumberANDA040882
Labeler NameAmneal Pharmaceuticals LLC
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength6 mg/5mL
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65162-678-86

118 mL in 1 BOTTLE (65162-678-86)
Marketing Start Date2009-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-678-90 [65162067890]

Promethazine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA040882
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-30

NDC 65162-678-86 [65162067886]

Promethazine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA040882
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-30

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:afb16e94-03bf-4ea2-b2fe-e65f274e55a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992432
    • UPC Code
  • 0365162678864

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]

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

    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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