"0121-1544-40" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 4 TRAY in 1 CASE (0121-1544-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1544-10)
(PAI Holdings, LLC dba PAI Pharma)

NDC Code0121-1544-40
Package Description4 TRAY in 1 CASE (0121-1544-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1544-10)
Product NDC0121-1544
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
Strength217; 5
Strength Unitmg/10mL; mg/10mL
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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