"13107-004-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Ibuprofen 100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)
(Aurolife Pharma, LLC)

NDC Code13107-004-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)
Product NDC13107-004
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Ibuprofen
Non-Proprietary NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20160602
Marketing Category NameANDA
Application NumberANDA204575
ManufacturerAurolife Pharma, LLC
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Strength7.5; 200
Strength Unitmg/1; mg/1
Pharmacy ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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