"80425-0539-3" National Drug Code (NDC)

Bupropion Hydrochloride 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-3)
(Advanced Rx of Tennessee, LLC)

NDC Code80425-0539-3
Package Description90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-3)
Product NDC80425-0539
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBupropion Hydrochloride
Proprietary Name Suffix(xl)
Non-Proprietary NameBupropion Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20250829
Marketing Category NameANDA
Application NumberANDA207479
ManufacturerAdvanced Rx of Tennessee, LLC
Substance NameBUPROPION HYDROCHLORIDE
Strength300
Strength Unitmg/1
Pharmacy ClassesAminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]

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