Baclofen
- Product NDC
- 68071-2414
- 11-digit product format
- 680712414
- Labeler code
- 68071
- Product ID
- 68071-2414_e6607b0c-7d83-22cb-e053-2995a90acc76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2020-10-09
- Marketing end
- 0000-00-00
- Substance
- BACLOFEN
- Active strength
- 10 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68071-2414 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 68071-2414 | 68071-2414-3 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 68071-2414 | 68071-2414-4 | I | Inactivated by FDA | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2414-3 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2414-4 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2414-3 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2414-4 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-2414-3 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-2414-4 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-2414-3 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-2414-4 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-2414-3 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-2414-4 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-2414-3 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-2414-4 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-2414-3 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-2414-4 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-2414-3 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-2414-4 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-2414-3 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-2414-4 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212378-001 | BACLOFEN | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | |
| A212378-002 | BACLOFEN | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | |
| A212378-003 | BACLOFEN | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212378-001 | AB |
| A212378-002 | AB |
| A212378-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212378-002 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2020-10-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212378-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-04-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212378-001 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2020-10-09 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212378-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212378-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212378-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212378-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212378-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212378-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212378-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212378-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212378-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212378-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212378-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212378-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212378-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212378-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212378-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212378-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212378-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212378-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212378-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212378-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212378-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212378-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212378-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212378-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212378-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212378-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212378-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212378-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212378-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212378-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212378-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212378-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212378-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212378-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212378-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212378-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212378-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212378-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212378-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212378-001 | AB | 1 | 8072bd15b7f6… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2414-3 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7b39-d83d-e063-dadaa90ab31f | Baclofen Tablets, USP Rx only |
| 68071-2414-4 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7b39-d83d-e063-dadaa90ab31f | Baclofen Tablets, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2414-3 | Baclofen | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 68071-2414-4 | Baclofen | 40 in 1 BOTTLE | TABLET | 40 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2414 | BACLOFEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Legacy NDC, 2 package rows | 20220818_c31518c9-b3b5-acc7-e053-2995a90a27d9.zip |
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 | REMEDYREPACK INC. | 6274e70a-fb57-461b-b1bc-39d4ff916b2a | 2026-07-14 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | d689d32c-12a7-4ae4-afc3-8a353be67148 | 2026-06-01 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 80b0a41e-2cad-4e14-9605-0cd35f9991e9 | 2026-02-05 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 808113db-c5c2-404c-ab5f-62b991641cfe | 2026-01-12 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 8a39dbc7-99d7-49e4-b5a1-cf70e7d753b2 | 2025-11-12 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 0a5940cd-63eb-4d1b-8e92-44df264bc05a | 2025-10-03 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Method Pharmaceuticals LLC | 1a9db542-d2b0-141a-e063-6394a90acc11 | 2025-07-23 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | a748da19-d3eb-499e-986c-2043a1356f2b | 2025-07-15 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 3ac0f0d2-86d8-46d0-88e5-c243734b0814 | 2025-06-26 | Warnings, Adverse reactions | 212378 ANDA212378 |
| BACLOFEN | BACLOFEN | XLCare Pharmaceuticals Inc. | 2b4908fb-47b5-4675-be9e-ca1ad48a7252 | 2025-02-05 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | c85a1884-f46f-5cd4-e053-2a95a90a3e27 | 2024-12-31 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | ec09736a-dd2b-0a3b-e053-2995a90a9542 | 2024-12-31 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 43cafbdb-6927-45f6-9b16-3b125cc2a29d | 2024-11-27 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | f5edb656-4f7e-2386-e053-2995a90a70de | 2024-11-15 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 08a6866f-b127-482f-9f22-113175487bdd | 2024-09-12 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4634093b-6def-41d6-a7f3-23040125c4f4 | 2024-09-03 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 655db2a3-daf7-4f4b-8f64-4a6d81fdc165 | 2024-09-03 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | d24135b3-e247-412f-a10b-ceecbdee3aef | 2024-04-02 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 80a4c6f7-4f02-493c-9263-62e1c90404ba | 2024-04-02 | Warnings, Adverse reactions | 212378 ANDA212378 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | ff8e9fa8-5f06-4902-b1ac-a7fc09ccddbb | 2024-01-09 | Warnings, Adverse reactions | 212378 ANDA212378 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197391 | baclofen 10 MG Oral Tablet | PSN | c31518c9-b3b5-acc7-e053-2995a90a27d9 | 2 |
| 197391 | baclofen 10 MG Oral Tablet | SCD | c31518c9-b3b5-acc7-e053-2995a90a27d9 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-2414-3 | 68071241403 | 30 TABLET in 1 BOTTLE (68071-2414-3) | 30 tablet | 2021-05-24 | 0000-00-00 | No | No | Current |
| 68071-2414-4 | 68071241404 | 40 TABLET in 1 BOTTLE (68071-2414-4) | 40 tablet | 2021-05-24 | 0000-00-00 | No | No | Current |