NDC 50383-803

Promethazine Hydrochloride and Dextromethophan Hydrobromide

Promethazine Hydrochloride And Dextromethophan Hydrobromide

Promethazine Hydrochloride and Dextromethophan Hydrobromide is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Dextromethorphan Hydrobromide; Promethazine Hydrochloride.

Product ID50383-803_852fa99c-9d1e-4175-a481-b31650c8525b
NDC50383-803
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride and Dextromethophan Hydrobromide
Generic NamePromethazine Hydrochloride And Dextromethophan Hydrobromide
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1996-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA040027
Labeler NameAkorn
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength15 mg/5mL; mg/5mL
Pharm ClassesPhenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50383-803-04

118 mL in 1 BOTTLE (50383-803-04)
Marketing Start Date1996-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-803-16 [50383080316]

Promethazine Hydrochloride and Dextromethophan Hydrobromide SOLUTION
Marketing CategoryANDA
Application NumberANDA040027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-07-31

NDC 50383-803-04 [50383080304]

Promethazine Hydrochloride and Dextromethophan Hydrobromide SOLUTION
Marketing CategoryANDA
Application NumberANDA040027
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-07-31

NDC 50383-803-08 [50383080308]

Promethazine Hydrochloride and Dextromethophan Hydrobromide SOLUTION
Marketing CategoryANDA
Application NumberANDA040027
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-07-31

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:3b78df0c-2c83-41e7-a964-7de0d11c423b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991528
  • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]
    • Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
    • Sigma-1 Agonist [EPC]
    • Uncompetitive NMDA Receptor Antagonists [MoA]
    • Sigma-1 Receptor Agonists [MoA]
    • Phenothiazine [EPC]
    • Phenothiazines [CS]
    • Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
    • Sigma-1 Agonist [EPC]
    • Uncompetitive NMDA Receptor Antagonists [MoA]
    • Sigma-1 Receptor Agonists [MoA]

    Medicade Reported Pricing

    50383080316 PROMETHAZINE-DM SOLUTION

    Pricing Unit: ML | Drug Type:

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