"0406-0378-23" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 1 TABLET in 1 BLISTER PACK (0406-0378-23)
(SpecGx LLC)

NDC Code0406-0378-23
Package Description1 TABLET in 1 BLISTER PACK (0406-0378-23)
Product NDC0406-0378
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20170331
Marketing Category NameANDA
Application NumberANDA206718
ManufacturerSpecGx LLC
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength300; 10
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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