"52125-596-01" National Drug Code (NDC)

Prometh With Codeine 118 mL in 1 BOTTLE (52125-596-01)
(REMEDYREPACK INC.)

NDC Code52125-596-01
Package Description118 mL in 1 BOTTLE (52125-596-01)
Product NDC52125-596
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePrometh With Codeine
Non-Proprietary NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSYRUP
UsageORAL
Start Marketing Date20130708
Marketing Category NameANDA
Application NumberANDA088763
ManufacturerREMEDYREPACK INC.
Substance NameCODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Strength10; 6.25
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]

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