"53746-117-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Ibuprofen 100 TABLET in 1 BOTTLE (53746-117-01)
(Amneal Pharmaceuticals of New York LLC)

NDC Code53746-117-01
Package Description100 TABLET in 1 BOTTLE (53746-117-01)
Product NDC53746-117
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Ibuprofen
Non-Proprietary NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTABLET
UsageORAL
Start Marketing Date20100218
Marketing Category NameANDA
Application NumberANDA076642
ManufacturerAmneal Pharmaceuticals of New York LLC
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Strength10; 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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