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United States· US:71610-774_edf166e7-bcf0-4bda-97ea-d9b82140aab3

Bupropion Hydrochloride

A medicinal product containing bupropion hydrochloride, registered in United States by Aphena Pharma Solutions - Tennessee, LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedBupropion HydrochlorideATC—REGISTER NO.US:71610-774_edf166e7…PACKS LISTED8CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
BUPROPION HYDROCHLORIDE
Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 8

  • ndc11
    7161077453
    60 TABLET, FILM COATED in 1 BOTTLE (71610-774-53)
  • ndc11
    7161077470
    120 TABLET, FILM COATED in 1 BOTTLE (71610-774-70)
  • ndc11
    7161077480
    180 TABLET, FILM COATED in 1 BOTTLE (71610-774-80)
  • ndc11
    7161077494
    360 TABLET, FILM COATED in 1 BOTTLE (71610-774-94)
  • ndc11
    71610-774-53
  • ndc11
    71610-774-70
  • ndc11
    71610-774-80
  • ndc11
    71610-774-94

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Bupropion hydrochloride in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All bupropion hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Bupropion !$tada, Bupropion +pharma
  • Belgium · Bupropion Eg, Bupropion Sandoz
  • Cyprus · Wellbutrin Xr
  • Czechia · Bupropion +pharma, Bupropion Neuraxpharm
  • Germany · Bupropion, Bupropion 1 A Pharma
  • Denmark · Bupropion Hydrochloride Zentiva, Bupropionhydrochlorid Stada
  • Estonia · Elontril
  • Spain · Bupropion Accord, Bupropión Cinfa
  • Finland · Bupropion Accord, Bupropion Omet Pharma
  • France · Zyban L.P.
  • United Kingdom (Northern Ireland) · Zyban
  • Greece · Wellbutrin Xr
  • Croatia · Bupropion Genericon, Wellbutrin Xr
  • Hungary · Elontril
  • Ireland · Zyban
  • Iceland · Bupropion Teva, Wellbutrin Retard
  • Italy · Bupropion Sun, Bupropione Doc
  • Lithuania · Elontril
  • Luxembourg · Bupropion Eg, Bupropion Ratiopharm
  • Latvia · Wellbutrin Sr
  • Malta · Bupropion Generis, Wellbutrin Xr
  • Netherlands · Bupropion Hcl 1a Retard 1a Pharma, Bupropion Hcl Accord
  • Norway · Bupropion Hydrochloride Teva, Bupropion Hydrochloride Zentiva
  • Poland · Bucidar, Bupropion
  • Portugal · Bupropiom Generis, Bupropiom Ratiopharm
  • Romania · Axabal, Elontril
  • Sweden · Bupropion Accord, Bupropion Bluefish
  • Slovenia · Bupropion Accord, Wellbutrin Xr
  • Slovakia · Bupropion Neuraxpharm, Elontril

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/efab4e6e-d7cf-4288-8685-e43d956f49a8
GET /v1/drugs/efab4e6e-d7cf-4288-8685-e43d956f49a8?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "75",
  "substance": "BUPROPION HYDROCHLORIDE",
  "productndc": "71610-774",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA076143",
  "marketing_category": "ANDA"
}

See everything about bupropion hydrochloride.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.