"76218-1828-5" National Drug Code (NDC)

Hydrocodone Bitartate And Acetaminophen 500 TABLET in 1 BOTTLE (76218-1828-5)
(KLE 2, Inc.)

NDC Code76218-1828-5
Package Description500 TABLET in 1 BOTTLE (76218-1828-5)
Product NDC76218-1828
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate, Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20120517
Marketing Category NameANDA
Application NumberANDA040846
ManufacturerKLE 2, Inc.
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength325; 2.5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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