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PROMETHAZINE DM - 52125-647-01 - (Dextromethorphan Hydrobromide and Promethazine Hydrochloride)

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Drug Information of PROMETHAZINE DM

Product NDC: 52125-647
Proprietary Name: PROMETHAZINE DM
Non Proprietary Name: Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Active Ingredient(s): 15; 6.25    mg/5mL; mg/5mL & nbsp;   Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Administration Route(s): ORAL
Dosage Form(s): SYRUP
Coding System: National Drug Codes(NDC)

Labeler Information of PROMETHAZINE DM

Product NDC: 52125-647
Labeler Name: REMEDYREPACK INC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040649
Marketing Category: ANDA
Start Marketing Date: 20130617

Package Information of PROMETHAZINE DM

Package NDC: 52125-647-01
Package Description: 118 mL in 1 BOTTLE (52125-647-01)

NDC Information of PROMETHAZINE DM

NDC Code 52125-647-01
Proprietary Name PROMETHAZINE DM
Package Description 118 mL in 1 BOTTLE (52125-647-01)
Product NDC 52125-647
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage Form Name SYRUP
Route Name ORAL
Start Marketing Date 20130617
Marketing Category Name ANDA
Labeler Name REMEDYREPACK INC.
Substance Name DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Strength Number 15; 6.25
Strength Unit mg/5mL; mg/5mL
Pharmaceutical Classes 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 [Chemical/Ingredient]

Complete Information of PROMETHAZINE DM


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