"51862-216-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 100 TABLET in 1 BOTTLE, PLASTIC (51862-216-01)
(Mayne Pharma Inc.)

NDC Code51862-216-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (51862-216-01)
Product NDC51862-216
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20140401
Marketing Category NameANDA
Application NumberANDA090118
ManufacturerMayne Pharma Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength7.5; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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