"43386-358-05" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 500 TABLET in 1 BOTTLE (43386-358-05)
(Lupin Pharmaceuticals,Inc.)

NDC Code43386-358-05
Package Description500 TABLET in 1 BOTTLE (43386-358-05)
Product NDC43386-358
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20161201
Marketing Category NameANDA
Application NumberANDA206245
ManufacturerLupin Pharmaceuticals,Inc.
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength325; 10
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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