"64850-631-60" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 60 TABLET in 1 BOTTLE, PLASTIC (64850-631-60)
(Elite Laboratories, Inc.)

NDC Code64850-631-60
Package Description60 TABLET in 1 BOTTLE, PLASTIC (64850-631-60)
Product NDC64850-631
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20181116
Marketing Category NameANDA
Application NumberANDA209924
ManufacturerElite Laboratories, Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength5; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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