Baclofen
- Product NDC
- 68071-3001
- Requested package NDC
- 68071-3001-6
- 11-digit product format
- 680713001
- Labeler code
- 68071
- Product ID
- 68071-3001_bb122c6d-6b76-f77e-e053-2a95a90ac059
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA077241
- Marketing category
- ANDA
- Marketing start
- 2005-12-01
- 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
- 2022-12-31
- 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 package | package | 68071-3001 | 68071-3001-6 | D | Discontinued by firm | 2026-08-10 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077241-001 | BACLOFEN | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | |
| A077241-002 | BACLOFEN | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | |
| A077241-003 | BACLOFEN | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077241-001 | AB |
| A077241-002 | AB |
| A077241-003 | 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 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 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 | A077241-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077241-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077241-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077241-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 68071-3001-2 | 2023-07-12 | BACLOFEN TABLETS, USP |
| 68071-3001-3 | 2023-07-12 | BACLOFEN TABLETS, USP |
| 68071-3001-6 | 2023-07-12 | BACLOFEN TABLETS, USP |
| 68071-3001-9 | 2023-07-12 | BACLOFEN TABLETS, USP |
| 68071-3001-2 | 2023-01-30 | BACLOFEN TABLETS, USP |
| 68071-3001-3 | 2023-01-30 | BACLOFEN TABLETS, USP |
| 68071-3001-6 | 2023-01-30 | BACLOFEN TABLETS, USP |
| 68071-3001-9 | 2023-01-30 | BACLOFEN TABLETS, USP |
| 68071-3001-2 | 2021-02-11 | BACLOFEN TABLETS, USP |
| 68071-3001-3 | 2021-02-11 | BACLOFEN TABLETS, USP |
| 68071-3001-6 | 2021-02-11 | BACLOFEN TABLETS, USP |
| 68071-3001-9 | 2021-02-11 | BACLOFEN TABLETS, USP |
| 68071-3001-2 | 2021-01-29 | BACLOFEN TABLETS, USP |
| 68071-3001-3 | 2021-01-29 | BACLOFEN TABLETS, USP |
| 68071-3001-6 | 2021-01-29 | BACLOFEN TABLETS, USP |
| 68071-3001-9 | 2021-01-29 | BACLOFEN TABLETS, USP |
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 | Cardinal Health 107, LLC | 2278954a-7605-426a-ae85-1bf0a3117420 | 2026-04-22 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Major Pharmaceuticals | ae732bdc-5178-4565-8219-d1787a5211a6 | 2026-01-09 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | cfcf519f-5d15-431d-89c8-961a0c38ba60 | 2025-10-17 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Marlex Pharmaceuticals Inc | 1b0f50c8-62e3-414d-96d3-5fd16e8043ab | 2025-09-22 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | b4f2f888-979a-6f54-e053-2a95a90a95a3 | 2024-12-31 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Chartwell RX, LLC | 2a75db96-590a-43cf-aefb-3bbcb287dbf0 | 2024-10-10 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7f27f935-b1fa-4494-9014-7f62c59bb8e3 | 2024-01-30 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | b4506087-be24-4e76-9fb8-b07805137072 | 2024-01-10 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | c582972d-22ef-4326-b37f-adf2ca0b1875 | 2023-12-21 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 58816b46-28a5-48e2-b89d-98df65939386 | 2023-10-20 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 9110b1cb-8604-4824-9337-84b08d41dd3c | 2023-10-20 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Lannett Company, Inc. | f84f3f4c-17e6-43f1-9600-63b0b175837b | 2021-02-24 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Proficient Rx LP | 924a01fb-0ed0-4f73-9304-d6c5b9961d66 | 2020-05-01 | Warnings, Adverse reactions | 077241 ANDA077241 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-3001-6 | 68071300106 | 60 TABLET in 1 BOTTLE (68071-3001-6) | 60 tablet | 2017-03-29 | 0000-00-00 | No | No | Current |