Bupropion Hydrochloride
- Product NDC
- 70518-0227
- 11-digit product format
- 705180227
- Labeler code
- 70518
- Product ID
- 70518-0227_82f6a74e-e2a8-4b22-e053-2a91aa0aa2e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077285
- Marketing category
- ANDA
- Marketing start
- 2017-02-15
- Marketing end
- 0000-00-00
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-0227 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70518-0227 | 70518-0227-0 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077285-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2008-11-26 | |
| A077285-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2008-08-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077285-001 | AB3 |
| A077285-002 | AB3 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A077285-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2008-11-26 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A077285-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2008-08-15 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A077285-001 | AB3 | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A077285-002 | AB3 | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Actavis Pharma, Inc. | df923448-4f81-47af-8e55-f7359746b05f | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 077285 ANDA077285 |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | HAWAII REPACK, INC. | b4a1d3b8-afcf-47e3-96d3-469d8f408a31 | 2025-06-11 | Boxed warning, Warnings, Adverse reactions | 077285 ANDA077285 |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Asclemed USA, Inc. | 637e89e5-8f6e-4392-8045-a778cb9ed138 | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | 077285 ANDA077285 |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Proficient Rx LP | 9e2d9c1e-a1de-491d-8f64-34ae60419611 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 077285 ANDA077285 |