"12634-975-04" National Drug Code (NDC)

Acetaminophen And Codeine Phosphate 120 mL in 1 BOTTLE (12634-975-04)
(APOTHECA, INC.)

NDC Code12634-975-04
Package Description120 mL in 1 BOTTLE (12634-975-04)
Product NDC12634-975
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAcetaminophen And Codeine Phosphate
Non-Proprietary NameAcetaminophen And Codeine Phosphate
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20090904
Marketing Category NameANDA
Application NumberANDA040119
ManufacturerAPOTHECA, INC.
Substance NameACETAMINOPHEN; CODEINE PHOSPHATE
Strength120; 12
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCV

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