Baclofen
- Product NDC
- 68788-9735
- 11-digit product format
- 687889735
- Labeler code
- 68788
- Product ID
- 68788-9735_a4535e06-f1df-4596-a3b4-713e5c71ab16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA077068
- Marketing category
- ANDA
- Marketing start
- 2012-04-30
- Marketing end
- 0000-00-00
- Substance
- BACLOFEN
- Active strength
- 20 mg/1
- Pharmacologic classes
- GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 | 68788-9735 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68788-9735 | 68788-9735-1 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-9735 | 68788-9735-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-9735 | 68788-9735-6 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-9735 | 68788-9735-8 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-9735 | 68788-9735-9 | 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 |
|---|---|---|---|---|---|---|---|
| A077068-001 | BACLOFEN | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-08-30 | |
| A077068-002 | BACLOFEN | BACLOFEN | 10MG | TABLET / ORAL | AB | 2005-08-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077068-001 | AB |
| A077068-002 | AB |
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 | A077068-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-08-30 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A077068-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2005-08-30 | 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 | A077068-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A077068-002 | AB | 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 |
|---|---|---|---|---|---|---|
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7b6d33d8-58c2-448d-a8df-1de7339b1520 | 2024-12-12 | Warnings, Adverse reactions | 077068 ANDA077068 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4cbb2264-ef65-4906-86e5-349deeeda7a9 | 2024-12-05 | Warnings, Adverse reactions | 077068 ANDA077068 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 32525b4e-6384-49e1-a66d-abe45484ab86 | 2024-12-05 | Warnings, Adverse reactions | 077068 ANDA077068 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | e13c0563-0f32-4199-acb0-ad2376ec951b | 2024-12-05 | Warnings, Adverse reactions | 077068 ANDA077068 |
| Baclofen | BACLOFEN | Par Health USA, LLC | c17527be-661d-42f5-b6f6-56a681ba7870 | 2024-11-07 | Warnings, Adverse reactions | 077068 ANDA077068 |