Baclofen
- Product NDC
- 68071-3075
- Requested package NDC
- 68071-3075-9
- 11-digit product format
- 680713075
- Labeler code
- 68071
- Product ID
- 68071-3075_bb12e55b-3bc4-f4c8-e053-2a95a90a2a1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078220
- Marketing category
- ANDA
- Marketing start
- 2007-07-01
- 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
- 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 | 68071-3075 | 68071-3075-9 | D | Discontinued by firm | 2026-10-12 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 68071-3075-3 | 2024-07-18 | BACLOFEN TABLETS, USP |
| 68071-3075-6 | 2024-07-18 | BACLOFEN TABLETS, USP |
| 68071-3075-9 | 2024-07-18 | BACLOFEN TABLETS, USP |
| 68071-3075-3 | 2023-01-30 | BACLOFEN TABLETS, USP |
| 68071-3075-6 | 2023-01-30 | BACLOFEN TABLETS, USP |
| 68071-3075-9 | 2023-01-30 | BACLOFEN TABLETS, USP |
| 68071-3075-3 | 2021-02-11 | BACLOFEN TABLETS, USP |
| 68071-3075-6 | 2021-02-11 | BACLOFEN TABLETS, USP |
| 68071-3075-9 | 2021-02-11 | BACLOFEN TABLETS, USP |
| 68071-3075-3 | 2021-01-29 | BACLOFEN TABLETS, USP |
| 68071-3075-6 | 2021-01-29 | BACLOFEN TABLETS, USP |
| 68071-3075-9 | 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 | 078220 ANDA078220 |
| Baclofen | BACLOFEN | Preferred Pharmaceuticals, Inc. | 58416ceb-994f-4571-afbd-c2171823f528 | 2026-01-26 | Warnings, Adverse reactions | 078220 ANDA078220 |
| Baclofen | BACLOFEN | Major Pharmaceuticals | ae732bdc-5178-4565-8219-d1787a5211a6 | 2026-01-09 | Warnings, Adverse reactions | 078220 ANDA078220 |
| Baclofen | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | cfcf519f-5d15-431d-89c8-961a0c38ba60 | 2025-10-17 | Warnings, Adverse reactions | 078220 ANDA078220 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f | 2024-01-30 | Warnings, Adverse reactions | 078220 ANDA078220 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 402a0a2b-95a6-4d22-bedf-826e1f1cd2c3 | 2024-01-11 | Warnings, Adverse reactions | 078220 ANDA078220 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 54bea140-c537-44a2-8d1d-bfb20471f4d8 | 2024-01-10 | Warnings, Adverse reactions | 078220 ANDA078220 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 12d57610-8c70-4729-b358-56525613a29d | 2024-01-10 | Warnings, Adverse reactions | 078220 ANDA078220 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | fded79a4-c354-448d-96dd-6dc69c46a013 | 2023-10-19 | Warnings, Adverse reactions | 078220 ANDA078220 |
| Baclofen | BACLOFEN | Lannett Company, Inc. | f84f3f4c-17e6-43f1-9600-63b0b175837b | 2021-02-24 | Warnings, Adverse reactions | 078220 ANDA078220 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | d9e5a8b9-1524-41b4-942f-f95015dd17f9 | 2020-08-05 | Warnings, Adverse reactions | 078220 ANDA078220 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-3075-9 | 68071307509 | 90 TABLET in 1 BOTTLE (68071-3075-9) | 90 tablet | 2018-06-26 | 0000-00-00 | No | No | Current |