NDC 53002-1508

Bupropion hydrochloride (XL)

Bupropion Hydrochloride

Bupropion hydrochloride (XL) is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Bupropion Hydrochloride.

Product ID53002-1508_0f6ec605-150f-4772-9caa-f8b4507e83e0
NDC53002-1508
Product TypeHuman Prescription Drug
Proprietary NameBupropion hydrochloride (XL)
Generic NameBupropion Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-01-08
Marketing CategoryANDA / ANDA
Application NumberANDA208652
Labeler NameRPK 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
Listing Certified Through2019-12-31

Packaging

NDC 53002-1508-3

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-1508-3)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-1508-3 [53002150803]

Bupropion hydrochloride (XL) TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208652
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:fe1db54b-d9ef-40b4-bc89-1369be50936a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993557

    • 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 (XL)" or generic name "Bupropion Hydrochloride"

    NDCBrand NameGeneric Name
    68001-322Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    68001-321Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    68788-6809Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    68788-7347Bupropion hydrochloride (XL)Bupropion hydrochloride (XL)
    68788-6931Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    69097-876Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    69097-875Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    70518-0436Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    70518-1229Bupropion hydrochloride (XL)Bupropion hydrochloride (XL)
    71205-076Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    71205-045Bupropion hydrochloride (XL)Bupropion hydrochloride (XL)
    71335-0824Bupropion hydrochloride (XL)Bupropion hydrochloride (XL)
    71335-0313Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    76282-480Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    76282-481Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    0615-8179Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    0781-5528Bupropion hydrochloride (XL)Bupropion hydrochloride (XL)
    0781-5529Bupropion hydrochloride (XL)Bupropion hydrochloride (XL)
    24979-101Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    24979-102Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    43598-655Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    43598-656Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    50228-144Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    50090-4169Bupropion hydrochloride (XL)Bupropion hydrochloride (XL)
    50228-145Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    53002-1508Bupropion hydrochloride (XL)Bupropion hydrochloride (XL)
    55648-102Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    61919-069BUPROPION HYDROCHLORIDE (XL)BUPROPION HYDROCHLORIDE (XL)
    64679-102Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    67046-081Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    71205-248Bupropion hydrochloride (XL)Bupropion hydrochloride (XL)
    51407-207Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    51407-206Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    71335-1114Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    71610-346Bupropion Hydrochloride (XL)Bupropion Hydrochloride (XL)
    0615-8241Bupropion Hydrochloride (XL)Bupropion Hydrochloride (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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.