"64850-630-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 100 TABLET in 1 BOTTLE, PLASTIC (64850-630-01)
(Elite Laboratories, Inc.)

NDC Code64850-630-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (64850-630-01)
Product NDC64850-630
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 NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength325; 2.5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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