"0245-0412-11" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 100 TABLET in 1 BOTTLE (0245-0412-11)
(Upsher-Smith Laboratories, LLC)

NDC Code0245-0412-11
Package Description100 TABLET in 1 BOTTLE (0245-0412-11)
Product NDC0245-0412
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20170327
Marketing Category NameANDA
Application NumberANDA206484
ManufacturerUpsher-Smith Laboratories, LLC
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength325; 10
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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