"57664-281-08" National Drug Code (NDC)

Hydrocodone Bitartrate And Ibuprofen 100 TABLET, FILM COATED in 1 BOTTLE (57664-281-08)
(Sun Pharmaceutical Industries, Inc.)

NDC Code57664-281-08
Package Description100 TABLET, FILM COATED in 1 BOTTLE (57664-281-08)
Product NDC57664-281
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Ibuprofen
Non-Proprietary NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20130528
Marketing Category NameANDA
Application NumberANDA091633
ManufacturerSun Pharmaceutical Industries, Inc.
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Strength2.5; 200
Strength Unitmg/1; mg/1
Pharmacy ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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