NDC 0378-2009

Bupropion Hydrochloride

Bupropion Hydrochloride

Bupropion Hydrochloride is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Bupropion Hydrochloride.

Product ID0378-2009_116e58a5-3927-4360-b0be-bf08fc47c5d1
NDC0378-2009
Product TypeHuman Prescription Drug
Proprietary NameBupropion Hydrochloride
Generic NameBupropion Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-09-28
Marketing End Date2019-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA090942
Labeler NameMylan Pharmaceuticals Inc.
Substance NameBUPROPION HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesAminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0378-2009-05

500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2009-05)
Marketing Start Date2010-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2009-77 [00378200977]

Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-28
Marketing End Date2014-10-07

NDC 0378-2009-05 [00378200905]

Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090942
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-28
Marketing End Date2019-11-30

NDC 0378-2009-93 [00378200993]

Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-28
Marketing End Date2014-10-07

Drug Details

Active Ingredients

IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:59a7cda8-34b4-4c02-b100-91f274918eef
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993557
  • 993541
    • UPC Code
  • 0303782009057

    • 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" or generic name "Bupropion Hydrochloride"

    NDCBrand NameGeneric Name
    0115-5445Bupropion HydrochlorideBUPROPION HYDROCHLORIDE
    0115-6811Bupropion HydrochlorideBUPROPION HYDROCHLORIDE
    0185-0410Bupropion HydrochlorideBupropion Hydrochloride
    0185-0415Bupropion HydrochlorideBupropion Hydrochloride
    0185-1111Bupropion HydrochlorideBupropion Hydrochloride
    67544-892Bupropion HydrochlorideBupropion Hydrochloride
    68001-199Bupropion HydrochlorideBupropion Hydrochloride
    68001-198Bupropion HydrochlorideBupropion Hydrochloride
    68001-309Bupropion HydrochlorideBupropion Hydrochloride
    68001-308Bupropion HydrochlorideBupropion Hydrochloride
    68084-252Bupropion HydrochlorideBupropion Hydrochloride
    0440-7200Bupropion HydrochlorideBupropion Hydrochloride
    68084-697BuPROPion HydrochlorideBuPROPion Hydrochloride
    68084-708Bupropion HydrochlorideBupropion Hydrochloride
    68180-319Bupropion HydrochlorideBupropion Hydrochloride
    68180-320Bupropion HydrochlorideBupropion Hydrochloride
    68258-7157Bupropion hydrochlorideBupropion hydrochloride
    68258-7001Bupropion HydrochlorideBupropion Hydrochloride
    68788-6800Bupropion HydrochlorideBupropion Hydrochloride
    68788-6994Bupropion HydrochlorideBupropion Hydrochloride
    68788-6808Bupropion HydrochlorideBupropion Hydrochloride
    68788-7121Bupropion HydrochlorideBupropion Hydrochloride
    68788-7319bupropion Hydrochloridebupropion Hydrochloride
    68788-7170Bupropion HydrochlorideBupropion Hydrochloride
    68788-7221Bupropion HydrochlorideBupropion Hydrochloride
    68788-9781Bupropion HydrochlorideBupropion Hydrochloride
    68788-9524Bupropion HydrochlorideBupropion Hydrochloride
    69097-917bupropion Hydrochloridebupropion Hydrochloride
    69097-918bupropion Hydrochloridebupropion Hydrochloride
    69844-010bupropion hydrochloridebupropion hydrochloride
    69844-011bupropion hydrochloridebupropion hydrochloride
    70518-0414Bupropion HydrochlorideBupropion Hydrochloride
    70518-0227Bupropion HydrochlorideBupropion Hydrochloride
    70518-0897Bupropion HydrochlorideBupropion Hydrochloride
    70518-0900Bupropion HydrochlorideBupropion Hydrochloride
    70518-0788Bupropion HydrochlorideBupropion Hydrochloride
    70518-0349Bupropion HydrochlorideBupropion Hydrochloride
    70518-1437Bupropion HydrochlorideBupropion Hydrochloride
    70518-1189Bupropion HydrochlorideBupropion Hydrochloride
    70518-1468Bupropion HydrochlorideBupropion Hydrochloride
    70518-1566Bupropion HydrochlorideBupropion Hydrochloride
    70518-1584Bupropion HydrochlorideBupropion Hydrochloride
    70518-0859Bupropion HydrochlorideBupropion Hydrochloride
    70518-1711Bupropion HydrochlorideBupropion Hydrochloride
    71335-0013Bupropion HydrochlorideBupropion Hydrochloride
    71335-0019Bupropion HydrochlorideBupropion Hydrochloride
    71335-0331Bupropion HydrochlorideBupropion Hydrochloride
    71335-0502Bupropion HydrochlorideBupropion Hydrochloride
    71335-0687Bupropion HydrochlorideBupropion Hydrochloride
    71335-0791bupropion Hydrochloridebupropion Hydrochloride
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