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Prometh with Codeine - 0472-1627-08 - (promethazine hydrochloride and codeine phosphate)

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Drug Information of Prometh with Codeine

Product NDC: 0472-1627
Proprietary Name: Prometh with Codeine
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 Prometh with Codeine

Product NDC: 0472-1627
Labeler Name: Actavis Mid Atlantic LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA088763
Marketing Category: ANDA
Start Marketing Date: 20030103

Package Information of Prometh with Codeine

Package NDC: 0472-1627-08
Package Description: 237 mL in 1 BOTTLE (0472-1627-08)

NDC Information of Prometh with Codeine

NDC Code 0472-1627-08
Proprietary Name Prometh with Codeine
Package Description 237 mL in 1 BOTTLE (0472-1627-08)
Product NDC 0472-1627
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name promethazine hydrochloride and codeine phosphate
Dosage Form Name SYRUP
Route Name ORAL
Start Marketing Date 20030103
Marketing Category Name ANDA
Labeler Name Actavis Mid Atlantic LLC
Substance Name CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Strength Number 10; 6.25
Strength Unit mg/5mL; mg/5mL
Pharmaceutical Classes Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of Prometh with Codeine


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