NDC 50383-801

Promethazine Hydrochloride

Promethazine Hydrochloride

Promethazine Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Promethazine Hydrochloride.

Product ID50383-801_32d04a54-0c7b-4915-b8b4-9b1a94097c96
NDC50383-801
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride
Generic NamePromethazine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1998-09-25
Marketing CategoryANDA / ANDA
Application NumberANDA040026
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength6 mg/5mL
Pharm ClassesPhenothiazine [EPC], Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50383-801-04

118 mL in 1 BOTTLE (50383-801-04)
Marketing Start Date1998-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-801-08 [50383080108]

Promethazine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA040026
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-09-25

NDC 50383-801-04 [50383080104]

Promethazine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA040026
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-09-25

NDC 50383-801-16 [50383080116]

Promethazine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA040026
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1998-09-25

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:bd8d1f9a-242c-440b-a5eb-a50f64a1c1d9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992432

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]
    • Phenothiazine [EPC]
    • Phenothiazines [CS]

    Medicade Reported Pricing

    50383080116 PROMETHAZINE 6.25 MG/5 ML SYRP

    Pricing Unit: ML | Drug Type:

    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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