NDC 51655-003

Bupropion Hydrochloride ER

Bupropion Hydrochloride

Bupropion Hydrochloride ER is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Northwind Pharmaceuticals. The primary component is Bupropion Hydrochloride.

Product ID51655-003_cdec0059-c52f-4f86-8935-ae5da1f1b8c6
NDC51655-003
Product TypeHuman Prescription Drug
Proprietary NameBupropion Hydrochloride ER
Generic NameBupropion Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA078866
Labeler NameNorthwind Pharmaceuticals
Substance NameBUPROPION HYDROCHLORIDE
Active Ingredient Strength150 mg/1
Pharm ClassesAminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 51655-003-52

30 TABLET in 1 BOTTLE, DISPENSING (51655-003-52)
Marketing Start Date2014-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51655-003-26 [51655000326]

Bupropion Hydrochloride ER TABLET
Marketing CategoryANDA
Application NumberANDA078866
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01
Inactivation Date2020-01-31

NDC 51655-003-52 [51655000352]

Bupropion Hydrochloride ER TABLET
Marketing CategoryANDA
Application NumberANDA078866
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

OpenFDA Data

SPL SET ID:48d8965f-43e6-4160-a06d-a28995fe6e8a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993518
  • 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 Hydrochloride ER" or generic name "Bupropion Hydrochloride"

    NDCBrand NameGeneric Name
    51655-003Bupropion Hydrochloride ERBupropion Hydrochloride ER
    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.