"76420-215-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 100 TABLET in 1 BOTTLE (76420-215-01)
(Asclemed USA, Inc.)

NDC Code76420-215-01
Package Description100 TABLET in 1 BOTTLE (76420-215-01)
Product NDC76420-215
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20160412
Marketing Category NameANDA
Application NumberANDA202991
ManufacturerAsclemed USA, 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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