"12634-907-16" National Drug Code (NDC)

Promethazine Hydrochloride And Codeine Phosphate 473 mL in 1 BOTTLE (12634-907-16)
(Apotheca Inc.)

NDC Code12634-907-16
Package Description473 mL in 1 BOTTLE (12634-907-16)
Product NDC12634-907
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine Hydrochloride And Codeine Phosphate
Non-Proprietary NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSYRUP
UsageORAL
Start Marketing Date20100317
Marketing Category NameANDA
Application NumberANDA090180
ManufacturerApotheca 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 [CS]
DEA ScheduleCV

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