NDC 53217-279

Bupropion HydrochlorideXL XL

Bupropion Hydrochloride

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

Product ID53217-279_ae5cc052-7891-40e0-921e-ca706fc4877a
NDC53217-279
Product TypeHuman Prescription Drug
Proprietary NameBupropion HydrochlorideXL XL
Generic NameBupropion Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-11-26
Marketing CategoryANDA / ANDA
Application NumberANDA077715
Labeler NameAidarex Pharmaceuticals LLC
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-279-14

14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53217-279-14)
Marketing Start Date2008-11-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-279-99 [53217027999]

Bupropion HydrochlorideXL XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077715
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-26
Inactivation Date2020-01-31

NDC 53217-279-60 [53217027960]

Bupropion HydrochlorideXL XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-26
Inactivation Date2020-01-31

NDC 53217-279-90 [53217027990]

Bupropion HydrochlorideXL XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-26
Inactivation Date2020-01-31

NDC 53217-279-14 [53217027914]

Bupropion HydrochlorideXL XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-26
Inactivation Date2020-01-31

NDC 53217-279-30 [53217027930]

Bupropion HydrochlorideXL XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

OpenFDA Data

SPL SET ID:af94e1a9-fb47-4842-8cde-5b5f44fb83cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993541

    • 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 HydrochlorideXL XL" or generic name "Bupropion Hydrochloride"

    NDCBrand NameGeneric Name
    53217-279Bupropion HydrochlorideXL XLBupropion HydrochlorideXL XL
    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
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