NDC 70518-0639

WELLBUTRIN SR

Bupropion Hydrochloride

WELLBUTRIN SR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Bupropion Hydrochloride.

Product ID70518-0639_6bc4ad4e-5841-dc1d-e053-2a91aa0ab1ae
NDC70518-0639
Product TypeHuman Prescription Drug
Proprietary NameWELLBUTRIN SR
Generic NameBupropion Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-05-09
Marketing CategoryNDA / NDA
Application NumberNDA020358
Labeler NameREMEDYREPACK INC.
Substance NameBUPROPION HYDROCHLORIDE
Active Ingredient Strength100 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 70518-0639-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0639-0)
Marketing Start Date2018-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0639-0 [70518063900]

WELLBUTRIN SR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020358
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-25
Marketing End Date2020-04-07

Drug Details

Active Ingredients

IngredientStrength
BUPROPION HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:18aae35b-d55e-4fc1-a809-0ee1b135d7cf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993511
  • 993503
  • 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 "WELLBUTRIN SR" or generic name "Bupropion Hydrochloride"

    NDCBrand NameGeneric Name
    70518-0639WELLBUTRIN SRWELLBUTRIN SR
    61919-036WELLBUTRIN SRWELLBUTRIN SR
    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

    Trademark Results [WELLBUTRIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    WELLBUTRIN
    WELLBUTRIN
    73239586 1160590 Live/Registered
    Burroughs Wellcome Co.
    1979-11-19

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