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Promethazine Hydrochloride and Codeine Phosphate - 52125-587-01 - (Promethazine Hydrochloride and Codeine Phosphate)

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Drug Information of Promethazine Hydrochloride and Codeine Phosphate

Product NDC: 52125-587
Proprietary Name: Promethazine Hydrochloride and Codeine Phosphate
Non Proprietary Name: Promethazine Hydrochloride and Codeine Phosphate
Active Ingredient(s): 10; 6.25    mg/5mL; mg/5mL & nbsp;   Promethazine Hydrochloride and Codeine Phosphate
Administration Route(s): ORAL
Dosage Form(s): SYRUP
Coding System: National Drug Codes(NDC)

Labeler Information of Promethazine Hydrochloride and Codeine Phosphate

Product NDC: 52125-587
Labeler Name: REMEDYREPACK INC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040151
Marketing Category: ANDA
Start Marketing Date: 20130604

Package Information of Promethazine Hydrochloride and Codeine Phosphate

Package NDC: 52125-587-01
Package Description: 473 mL in 1 BOTTLE (52125-587-01)

NDC Information of Promethazine Hydrochloride and Codeine Phosphate

NDC Code 52125-587-01
Proprietary Name Promethazine Hydrochloride and Codeine Phosphate
Package Description 473 mL in 1 BOTTLE (52125-587-01)
Product NDC 52125-587
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Promethazine Hydrochloride and Codeine Phosphate
Dosage Form Name SYRUP
Route Name ORAL
Start Marketing Date 20130604
Marketing Category Name ANDA
Labeler Name REMEDYREPACK INC.
Substance Name CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Strength Number 10; 6.25
Strength Unit mg/5mL; mg/5mL
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]

Complete Information of Promethazine Hydrochloride and Codeine Phosphate


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