"0121-0772-04" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 118 mL in 1 BOTTLE (0121-0772-04)
(PAI Holdings, LLC dba PAI Pharma)

NDC Code0121-0772-04
Package Description118 mL in 1 BOTTLE (0121-0772-04)
Product NDC0121-0772
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20130729
Marketing Category NameANDA
Application NumberANDA040838
ManufacturerPAI Holdings, LLC dba PAI Pharma
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength325; 7.5
Strength Unitmg/15mL; mg/15mL
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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