"63304-497-05" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 500 TABLET in 1 BOTTLE (63304-497-05)
(Sun Pharmaceutical Industries, Inc.)

NDC Code63304-497-05
Package Description500 TABLET in 1 BOTTLE (63304-497-05)
Product NDC63304-497
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20180731
Marketing Category NameANDA
Application NumberANDA040826
ManufacturerSun Pharmaceutical Industries, 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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