"68387-230-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 100 TABLET in 1 BOTTLE, PLASTIC (68387-230-01)
(Keltman Pharmaceuticals Inc.)

NDC Code68387-230-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (68387-230-01)
Product NDC68387-230
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20100701
Marketing Category NameANDA
Application NumberANDA089699
ManufacturerKeltman Pharmaceuticals Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength7.5; 500
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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