NDC 71335-0801

bupropion

Bupropion Hydrochloride

bupropion is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Bupropion Hydrochloride.

Product ID71335-0801_4f041df8-4394-4e15-826f-08277266253d
NDC71335-0801
Product TypeHuman Prescription Drug
Proprietary Namebupropion
Generic NameBupropion Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA202304
Labeler NameBryant Ranch Prepack
Substance NameBUPROPION HYDROCHLORIDE
Active Ingredient Strength200 mg/1
Pharm ClassesAminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0801-1

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-1)
Marketing Start Date2022-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0801-2 [71335080102]

bupropion TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202304
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-03
Marketing End Date2019-08-31

NDC 71335-0801-4 [71335080104]

bupropion TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202304
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-03
Marketing End Date2019-08-31

NDC 71335-0801-1 [71335080101]

bupropion TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202304
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-03
Marketing End Date2019-08-31

NDC 71335-0801-5 [71335080105]

bupropion TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202304
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-03
Marketing End Date2019-08-31

NDC 71335-0801-3 [71335080103]

bupropion TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202304
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-03
Marketing End Date2019-08-31

NDC 71335-0801-6 [71335080106]

bupropion TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202304
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-03
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
BUPROPION HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:732690c9-eb8a-47a9-9cba-15d07df4e340
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993518
  • 993536
  • Pharmacological Class

    • Aminoketone [EPC]
    • Dopamine Uptake Inhibitors [MoA]
    • Increased Dopamine Activity [PE]
    • Increased Norepinephrine Activity [PE]
    • Norepinephrine Uptake Inhibitors [MoA]

    NDC Crossover Matching brand name "bupropion" or generic name "Bupropion Hydrochloride"

    NDCBrand NameGeneric Name
    68001-264bupropionbupropion
    68382-353bupropionbupropion
    68382-354bupropionbupropion
    68788-7249bupropionbupropion
    68788-9255bupropionbupropion
    70518-1644bupropionbupropion
    71335-0801bupropionbupropion
    71335-0785bupropionbupropion
    0615-8262bupropionbupropion
    43547-288bupropionbupropion
    43547-289bupropionbupropion
    43547-290bupropionbupropion
    50090-3854bupropionbupropion
    50436-0289bupropionbupropion
    55700-644bupropionbupropion
    63187-521bupropionbupropion
    65841-780bupropionbupropion
    65841-836bupropionbupropion
    70934-151bupropionbupropion
    63629-8036bupropionbupropion
    68788-7283bupropionbupropion
    68071-5214bupropionbupropion
    70518-2641bupropionbupropion
    51655-357bupropionbupropion
    71335-1622bupropionbupropion
    0115-5445Bupropion HydrochlorideBUPROPION HYDROCHLORIDE
    0115-6811Bupropion HydrochlorideBUPROPION HYDROCHLORIDE
    0185-0410Bupropion HydrochlorideBupropion Hydrochloride
    0185-0415Bupropion HydrochlorideBupropion Hydrochloride
    0185-1111Bupropion HydrochlorideBupropion Hydrochloride
    0173-0135WELLBUTRINbupropion hydrochloride
    0173-0722WELLBUTRINbupropion hydrochloride
    0173-0947WELLBUTRINbupropion hydrochloride
    0173-0556ZYBANbupropion hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.