DrugDashboards

Bupropion Hydrochloride

Bupropion Hydrochloride · BUPROPION 1 kg/kg · Powder · Zydus Lifesciences Limited

NDC 65841-0131-12 · 1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 5 kg in 1 BAG · BULK INGREDIENT · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (bulk ingredient) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

How Part D pricing works →

NADAC price per unit

ⓘ How this was built
Data sources
  • CMS NADAC weekly files (data.medicaid.gov), December 2024 onward
  • CMS NADAC per-year archive files, 2013 – November 2024, averaged per month
  • CMS Federal Upper Limit file — weighted average manufacturer price (WAMP) of the generic group (dashed line)
Method

One line, two regimes: before December 2024 each point is the average of that month's archived NADAC rows for this NDC; from December 2024 each point is a row from the weekly file, which CMS publishes only when the price changes, so the line holds flat until the next change and is extended to today when the last row is under 6 months old. Since the December 2024 file CMS computes generic NADAC as a 3-month moving average, so recent generic moves are smoothed and lag the market. The dashed WAMP is the manufacturer-side average for the whole multiple-source group, not this NDC alone. To check a point: open the NADAC file for that date on data.medicaid.gov and find this NDC.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NDCs that have a NADAC price and a generic name.

Regulatory

Application
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TE code
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Approval date
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Patents / exclusivity
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ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application (none), edition retrieved 2026-08-24
Method

Rows are the Orange Book's patent and exclusivity listings for this NDA, de-duplicated across product numbers (the file repeats a listing for every strength). A listed patent is a claim the sponsor filed; it may cover a use rather than the molecule, may be challenged, and may be delisted — a listing is not proof a generic is blocked. Pediatric extensions appear as *PED rows. FDA blocks automated downloads of the Orange Book from cloud servers, so the edition can trail FDA's monthly release; the retrieval date above is the edition shown. To check: search the application number on FDA's Orange Book site.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Shortage history

ⓘ How this was built
Data sources
  • FDA drug shortages via openFDA (current file: Current, To Be Discontinued, and recently Resolved rows)
  • Internet Archive (Wayback) snapshots of FDA's shortage list since 2019, reconstructed into episodes
  • DrugDashboards Kaplan–Meier duration curves and conditional duration model
Method

Top rows are FDA's live listings whose package NDC is this product or another package of the same generic name and dosage form. openFDA drops resolved rows after about six months, so older episodes come from monthly Wayback snapshots of FDA's file, matched on the molecule with dosage-form words stripped (that matching can pull in other salts or forms of the same molecule — the presentation is shown so you can tell). 'Month N of a typical M' compares this episode's age with the Kaplan–Meier median for its form class (injectable, oral solid, other) over episodes since October 2019, open episodes censored; the resolution odds come from a model conditioned on the episode's age and reason. To check: FDA's drug shortage database, and web.archive.org for its history.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Not on FDA's current shortage list. Archived episodes below.

Archived episodes (FDA list history via Wayback, 2019+)
  • Planned discontinuation — Endo Pharmaceuticals. Inc., Tablet, Extended Release, 300 mg (NDC 10370-102-03) (listed as “Bupropion Hydrochloride Tablet, Extended Release”)Dec 28, 2023 → last seen Nov 25, 2024
  • Planned discontinuation — Endo Pharmaceuticals. Inc., Tablet, Extended Release, 300 mg (NDC 10370-102-50) (listed as “Bupropion Hydrochloride Tablet, Extended Release”)Dec 28, 2023 → last seen Nov 25, 2024
  • Planned discontinuation — Endo Pharmaceuticals. Inc., Tablet, Extended Release, 150 mg (NDC 10370-101-50) (listed as “Bupropion Hydrochloride Tablet, Extended Release”)Oct 2, 2023 → last seen Sep 29, 2024
  • Planned discontinuation — Endo Pharmaceuticals. Inc., Tablet, Extended Release, 150 mg (NDC 10370-101-03) (listed as “Bupropion Hydrochloride Tablet, Extended Release”)Oct 2, 2023 → last seen Sep 29, 2024
  • Planned discontinuation — Endo Pharmaceuticals. Inc., BUPROPION HYDROCHLORIDE, TABLET, EXTENDED RELEASE, 150 mg (NDC 10370-101-50) (listed as “BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE”)Oct 2, 2023 → last seen Dec 7, 2023
  • Planned discontinuation — Endo Pharmaceuticals. Inc., BUPROPION HYDROCHLORIDE, TABLET, EXTENDED RELEASE, 150 mg (NDC 10370-101-03) (listed as “BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE”)Oct 2, 2023 → last seen Dec 7, 2023
  • Planned discontinuation — GlaxoSmithKline, 150 mg (NDC 0173-0556-01) (listed as “Bupropion Hydrochloride (Zyban) Tablets”)Jun 28, 2019 → last seen Nov 21, 2020
  • Planned discontinuation — Mylan Pharmaceuticals Inc., 300 mg, 500 count bottle (NDC 0378-2009-05) (listed as “Bupropion Hydrochloride Extended-Release Tablets”)May 2, 2019 → last seen Nov 21, 2020

Showing 8 of 9 archived episodes.

Recalls (this NDC)

ⓘ How this was built
Data sources
  • FDA drug enforcement reports via openFDA
Method

Enforcement reports whose product NDC list includes this exact package NDC, newest first, with FDA's classification (I = reasonable probability of serious harm, II = temporary or reversible harm, III = unlikely to cause harm) and the recall's current status. Reports for other packages of the same drug are not shown here; 275 of the last year's Class I/II reports carry no NDC at all and cannot be matched. To check: search the recall number on openFDA or FDA's enforcement reports.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

No enforcement reports list this package NDC.

Labelers of Bupropion Hydrochloride (Powder)

25 labelers active in the last 30 days; 1not seen for 30+ days. Keyed on FDA's generic-name string — other salts or forms of the molecule are separate rosters.

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA), read daily since 2026-07-15 — labeler_name per package
  • DailyMed SPL establishment roles + name patterns → derived.labeler_kinds (repackager / manufacturer / unknown)
Method

One row per labeler that lists any package with this exact generic-name string and dosage form; strengths are combined. 'First seen' is the first daily snapshot that contained the labeler here (2026-07-15 for everything present at the start), 'last seen' the most recent; a labeler counts as active when seen in the last 30 days. Repackagers and relabelers are flagged when their own labels show only repack/relabel operations or their name matches a known repackager, and are excluded from every 'makers' count on this page. Listing is not volume: a labeler with a listed NDC may ship little or nothing. To check: search the generic name in FDA's NDC Directory and list the labelers.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

LabelerStrengthsFirst seenLast seen
Erregierre SpABUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 3, 2026
Hikal LimitedBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 3, 2026
Aarti Pharmalabs LimitedBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedBUPROPION HYDROCHLORIDE 25 kg/25kgJul 15, 2026Sep 2, 2026
Alivus Life Sciences LimitedBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Cadila Pharmaceuticals LimitedBUPROPION HYDROCHLORIDE 25 kg/25kgJul 15, 2026Sep 2, 2026
Chemeca Drugs Private LimitedBUPROPION HYDROCHLORIDE 25 kg/25kgJul 15, 2026Sep 2, 2026
Derivados QuimicosBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Divi's Laboratories LimitedBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Emnar Pharma Private LimitedBUPROPION HYDROBROMIDE 25 kg/25kgJul 15, 2026Sep 2, 2026
Hetero Drugs LimitedBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Ipca Laboratories LimitedBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Jubilant Biosys limitedBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Letco Medical, LlcBUPROPION HYDROCHLORIDE 1 g/gJul 15, 2026Sep 2, 2026
MediscaBUPROPION 1 g/gJul 15, 2026Sep 2, 2026
Olon SpABUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Professional Compounding Centers of AmericaBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Spectrum Chemicals and Laboratory ProductsBUPROPION HYDROCHLORIDE 1 g/gJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.BUPROPION HYDROCHLORIDE 25 kg/25kgJul 15, 2026Sep 2, 2026
Willow Birch Pharma, LLCBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.BUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Zhejiang Supor Pharmaceuticals Co., LtdBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedBUPROPION 1 kg/kgJul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedBUPROPION HYDROCHLORIDE 50 kg/50kgJul 15, 2026Aug 31, 2026
Dipharma Francis SrlBUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Aug 28, 2026
Professional Compounding Centers of America dba PCCABUPROPION HYDROCHLORIDE 1 kg/kgJul 15, 2026Jul 15, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 15, 2026.

Cite this page

DrugDashboards, "Bupropion Hydrochloride — NDC 65841-0131-12," retrieved September 4, 2026, https://drugdashboards.com/drug/65841013112.

Free to cite with attribution — see how the data is put together.