"42549-516-12" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 120 TABLET in 1 BOTTLE (42549-516-12)
(STAT Rx USA LLC)

NDC Code42549-516-12
Package Description120 TABLET in 1 BOTTLE (42549-516-12)
Product NDC42549-516
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20100422
Marketing Category NameANDA
Application NumberANDA040201
ManufacturerSTAT Rx USA LLC
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength7.5; 500
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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