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"72189-486-16" National Drug Code (NDC)

Promethazine/codeine 473 mL in 1 BOTTLE (72189-486-16)
(Direct_Rx)

NDC Code72189-486-16
Package Description473 mL in 1 BOTTLE (72189-486-16)
Product NDC72189-486
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine/codeine
Non-Proprietary NamePromethazine/codeine
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20230602
Marketing Category NameANDA
Application NumberANDA200386
ManufacturerDirect_Rx
Substance NameCODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Strength10; 6.25
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
DEA ScheduleCV

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