"76420-875-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 1 TABLET in 1 BOTTLE, PLASTIC (76420-875-01)
(Asclemed USA, Inc.)

NDC Code76420-875-01
Package Description1 TABLET in 1 BOTTLE, PLASTIC (76420-875-01)
Product NDC76420-875
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20141006
Marketing Category NameANDA
Application NumberANDA202214
ManufacturerAsclemed USA, Inc.
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength325; 5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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