Baclofen
- Product NDC
- 71335-0206
- Requested package NDC
- 71335-0206-2
- 11-digit product format
- 713350206
- Labeler code
- 71335
- Product ID
- 71335-0206_4ae2bd17-292a-499a-86a7-7ab8dde7a38c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078504
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- 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
- 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 package | package | 71335-0206 | 71335-0206-2 | 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… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-0206-0 | EA - Each | 71335-0206 | 98be0d61-ad0f-4692-bda4-48a132b4df81 | 1 | 2018-03-08 |
| 71335-0206-1 | EA - Each | 71335-0206 | b2288a52-544d-4d44-b2d6-489ea36e4ca2 | 1 | 2018-03-08 |
| 71335-0206-2 | EA - Each | 71335-0206 | 28010de7-ffb8-4b76-851e-ea38c012227f | 1 | 2018-03-08 |
| 71335-0206-3 | EA - Each | 71335-0206 | eb066e9a-c997-4611-a55c-e9adf1574acc | 1 | 2018-03-08 |
| 71335-0206-4 | EA - Each | 71335-0206 | b3ea9626-09d2-4b20-adc7-581104fd505f | 1 | 2018-03-08 |
| 71335-0206-5 | EA - Each | 71335-0206 | b4513959-8ab6-4ad7-a115-1963286d6de1 | 1 | 2018-03-08 |
| 71335-0206-6 | EA - Each | 71335-0206 | 6f49d8b8-5b43-4365-8afb-cf3fcef1c050 | 1 | 2018-03-08 |
| 71335-0206-7 | EA - Each | 71335-0206 | 163392e4-1ba2-447b-b489-02e2dfc561ea | 1 | 2018-03-08 |
| 71335-0206-8 | EA - Each | 71335-0206 | f2695d73-f48d-49ed-a10d-b42c8caad658 | 1 | 2018-03-08 |
| 71335-0206-9 | EA - Each | 71335-0206 | a8d38a9d-2fee-42b8-97f3-1d4a0dec7546 | 1 | 2018-03-08 |
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 | Proficient Rx LP | b65d3089-0412-487f-a1b4-66f0bc6f398e | 2022-03-01 | Warnings, Adverse reactions | 078504 ANDA078504 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0206-2 | 71335020602 | 120 TABLET in 1 BOTTLE (71335-0206-2) | 120 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |