NDC 54868-5927

Bupropion Hydrochloride Extended Release (XL)

Bupropion Hydrochloride

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

Product ID54868-5927_5157468f-8f49-4746-a2c2-91a2020537e3
NDC54868-5927
Product TypeHuman Prescription Drug
Proprietary NameBupropion Hydrochloride Extended Release (XL)
Generic NameBupropion Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-08-13
Marketing CategoryANDA / ANDA
Application NumberANDA077715
Labeler NamePhysicians Total Care, 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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 54868-5927-0

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (54868-5927-0)
Marketing Start Date2008-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54868-5927-1 [54868592701]

Bupropion Hydrochloride Extended Release (XL) TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077715
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-25
Inactivation Date2019-09-24

NDC 54868-5927-2 [54868592702]

Bupropion Hydrochloride Extended Release (XL) TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-08
Inactivation Date2019-09-24

NDC 54868-5927-0 [54868592700]

Bupropion Hydrochloride Extended Release (XL) TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-08-13
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

OpenFDA Data

SPL SET ID:82f5292b-b113-4f10-9469-04386fa8e9d4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993557
  • 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 Hydrochloride Extended Release (XL)" or generic name "Bupropion Hydrochloride"

    NDCBrand NameGeneric Name
    54868-5927Bupropion Hydrochloride Extended Release (XL)Bupropion Hydrochloride Extended Release (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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