NDC 0187-5811

Aplenzin

Bupropion Hydrobromide

Aplenzin is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Bupropion Hydrobromide.

Product ID0187-5811_23b09d2e-0c63-4d09-9612-ed7efd542729
NDC0187-5811
Product TypeHuman Prescription Drug
Proprietary NameAplenzin
Generic NameBupropion Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-04-23
Marketing CategoryNDA / NDA
Application NumberNDA022108
Labeler NameBausch Health US, LLC
Substance NameBUPROPION HYDROBROMIDE
Active Ingredient Strength348 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 Through2022-12-31

Packaging

NDC 0187-5811-07

7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-07)
Marketing Start Date2008-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-5811-07 [00187581107]

Aplenzin TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022108
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-04-23

NDC 0187-5811-30 [00187581130]

Aplenzin TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022108
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-04-23

Drug Details

Active Ingredients

IngredientStrength
BUPROPION HYDROBROMIDE348 mg/1

OpenFDA Data

SPL SET ID:6494d2d9-0ce4-4126-b1c7-49684395942b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993552
  • 993550
  • 993683
  • 993681
  • 993569
  • 993567
  • UPC Code
  • 0301875812300
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Aplenzin" or generic name "Bupropion Hydrobromide"

    NDCBrand NameGeneric Name
    0187-5810Aplenzinbupropion hydrobromide
    0187-5811Aplenzinbupropion hydrobromide
    0187-5812Aplenzinbupropion hydrobromide

    Trademark Results [Aplenzin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    APLENZIN
    APLENZIN
    78340327 not registered Dead/Abandoned
    Biovail Laboratories International SRL
    2003-12-12
    APLENZIN
    APLENZIN
    77594316 3650117 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2008-10-16

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