"60846-900-01" National Drug Code (NDC)

Reprexain 100 TABLET, FILM COATED in 1 BOTTLE (60846-900-01)
(Gemini Laboratories, LLC)

NDC Code60846-900-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE (60846-900-01)
Product NDC60846-900
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameReprexain
Non-Proprietary NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20131227
Marketing Category NameANDA
Application NumberANDA076642
ManufacturerGemini Laboratories, LLC
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Strength2.5; 200
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA ScheduleCII

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