NDC 67046-699

Bupropion XL

Bupropion

Bupropion XL is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Coupler Enterprises Inc. The primary component is Bupropion Hydrochloride.

Product ID67046-699_65067909-4e70-63b5-e053-2991aa0ae8a9
NDC67046-699
Product TypeHuman Prescription Drug
Proprietary NameBupropion XL
Generic NameBupropion
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-02-14
Marketing CategoryANDA / ANDA
Application NumberANDA090693
Labeler NameCoupler Enterprises Inc
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 Through2020-12-31

Packaging

NDC 67046-699-30

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-699-30)
Marketing Start Date2017-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67046-699-30 [67046069930]

Bupropion XL TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090693
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-14

Drug Details

Active Ingredients

IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

OpenFDA Data

SPL SET ID:650659e9-e160-1d04-e053-2a91aa0ae49a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993541
  • UPC Code
  • 0368180319023
  • 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 "Bupropion XL" or generic name "Bupropion"

    NDCBrand NameGeneric Name
    63187-521bupropionbupropion
    65841-780bupropionbupropion
    65841-836bupropionbupropion
    67046-699BupropionBupropion
    68001-264bupropionbupropion
    68382-353bupropionbupropion
    68382-354bupropionbupropion
    68788-9255bupropionbupropion

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