BACLOFEN
- Product NDC
- 52817-321
- 11-digit product format
- 528170321
- Labeler code
- 52817
- Product ID
- 52817-321_1645f54e-2eed-bd9b-e063-6294a90a848b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TruPharma LLC
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2018-04-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209102-001 | BACLOFEN | BACLOFEN | 5MG | TABLET / ORAL | AB | 2017-11-28 | |
| A209102-002 | BACLOFEN | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | |
| A209102-003 | BACLOFEN | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | |
| A209102-004 | BACLOFEN | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209102-001 | AB |
| A209102-002 | AB |
| A209102-003 | AB |
| A209102-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2017-11-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2017-11-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2017-11-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209102-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209102-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209102-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209102-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209102-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209102-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209102-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209102-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BACLOFEN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BACLOFEN | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| H789N3FKE8 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 68aa591e-ea98-4438-9a4a-4f7e9ea2b285 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e25d01b-2e92-4765-bec7-8a0fd7bdc346 | Product name | 2 | 20251208 |
| 1b1393e5-f2d8-42f5-a070-e3416d619667 | Product name | 1 | 20250804 |
| 88583480-702d-4dfe-a31c-9c00abd818f8 | Product name | 7 | 20250729 |
| 1cf3c538-592e-4b4b-869e-51d4bf3ca83d | Product name | 2 | 20240703 |
| 6e532d1f-e0b5-46eb-a2be-d70bd338df9d | Product name | 1 | 20220613 |
| ef6bc0bf-8134-f06b-70d9-4980df6f808e | Product name | 5 | 20210615 |
| eeec0918-7a2f-44bf-83d6-1216e507adbf | Product name | 3 | 20191217 |
| a5300adb-f538-4abb-a49e-f8f0b8d9ac75 | Product name | 1 | 20190611 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52817-321-00 | BACLOFEN | 1000 in 1 BOTTLE | TABLET | 1000 | 4 | |
| 52817-321-10 | BACLOFEN | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 52817-321-50 | BACLOFEN | 500 in 1 BOTTLE | TABLET | 500 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52817-321-00 | EA - Each | 52817-321 | cbdc2453-b045-4feb-ae75-28b52c0d2fa8 | 1 | 2018-05-09 |
| 52817-321-10 | EA - Each | 52817-321 | bd5a7c5f-f74b-4443-816c-82d151d08c17 | 1 | 2018-05-09 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | 9834e409-8633-4f99-8ac7-7fa298d01c44 | 2024-05-30 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | adc072b9-e48b-470d-9eb1-fd7b52c1f122 | 2024-05-29 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | TruPharma LLC | 68aa591e-ea98-4438-9a4a-4f7e9ea2b285 | 2024-04-17 | Warnings, Adverse reactions | 209102 ANDA209102 52817-321 |
| BACLOFEN | BACLOFEN | NCS HealthCare of KY, LLC dba Vangard Labs | 2927228a-7a3e-4e1d-ab5f-4407b00f6899 | 2023-05-31 | Warnings, Adverse reactions | 209102 ANDA209102 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52817-321-00 | 52817032100 | 1000 TABLET in 1 BOTTLE (52817-321-00) | 1000 tablet | 2018-04-01 | 0000-00-00 | No | No | Current |
| 52817-321-10 | 52817032110 | 100 TABLET in 1 BOTTLE (52817-321-10) | 100 tablet | 2018-04-01 | 0000-00-00 | No | No | Current |
| 52817-321-50 | 52817032150 | 500 TABLET in 1 BOTTLE (52817-321-50) | 500 tablet | 2018-04-01 | 0000-00-00 | No | No | Current |