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PROMETHAZINE WITH CODEINE - 12634-909-02 - (PROMETHAZINE WITH CODEINE)

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Drug Information of PROMETHAZINE WITH CODEINE

Product NDC: 12634-909
Proprietary Name: PROMETHAZINE WITH CODEINE
Non Proprietary Name: PROMETHAZINE WITH CODEINE
Active Ingredient(s): 10; 6.25    mg/5mL; mg/5mL & nbsp;   PROMETHAZINE WITH CODEINE
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Coding System: National Drug Codes(NDC)

Labeler Information of PROMETHAZINE WITH CODEINE

Product NDC: 12634-909
Labeler Name: Apotheca, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040151
Marketing Category: ANDA
Start Marketing Date: 20090601

Package Information of PROMETHAZINE WITH CODEINE

Package NDC: 12634-909-02
Package Description: 60 mL in 1 BOTTLE (12634-909-02)

NDC Information of PROMETHAZINE WITH CODEINE

NDC Code 12634-909-02
Proprietary Name PROMETHAZINE WITH CODEINE
Package Description 60 mL in 1 BOTTLE (12634-909-02)
Product NDC 12634-909
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name PROMETHAZINE WITH CODEINE
Dosage Form Name LIQUID
Route Name ORAL
Start Marketing Date 20090601
Marketing Category Name ANDA
Labeler Name Apotheca, Inc.
Substance Name CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Strength Number 10; 6.25
Strength Unit mg/5mL; mg/5mL
Pharmaceutical Classes Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]

Complete Information of PROMETHAZINE WITH CODEINE


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