"0378-0130-01" National Drug Code (NDC)

Propoxyphene Hydrochloride And Acetaminophen 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0130-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0130-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0130-01)
Product NDC0378-0130
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePropoxyphene Hydrochloride And Acetaminophen
Non-Proprietary NamePropoxyphene Hydrochloride And Acetaminophen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20091130
Marketing Category NameANDA
Application NumberANDA083978
ManufacturerMylan Pharmaceuticals Inc.
Substance NamePROPOXYPHENE HYDROCHLORIDE; ACETAMINOPHEN
Strength65; 650
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV

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