Gabapentin
- Product NDC
- 58657-720
- Requested package NDC
- 58657-720-50
- 11-digit product format
- 586570720
- Labeler code
- 58657
- Product ID
- 58657-720_edb5dd4a-354d-fb9c-e053-2995a90acb47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA207099
- Marketing category
- ANDA
- Marketing start
- 2017-03-24
- Marketing end
- 2022-12-31
- Substance
- GABAPENTIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 58657-720 | 58657-720-50 | D | Discontinued by firm | 2026-08-11 |
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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207099-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | |
| A207099-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | |
| A207099-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207099-001 | AB |
| A207099-002 | AB |
| A207099-003 | 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 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207099-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2017-03-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207099-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2017-03-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207099-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2017-03-24 | 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 | A207099-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207099-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207099-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207099-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207099-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207099-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207099-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207099-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207099-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207099-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207099-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207099-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207099-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207099-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207099-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207099-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207099-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207099-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207099-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207099-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207099-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207099-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207099-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207099-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207099-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207099-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207099-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207099-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207099-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207099-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207099-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207099-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207099-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207099-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207099-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207099-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207099-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207099-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207099-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207099-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| gabapentin | GABAPENTIN | REMEDYREPACK INC. | 32169228-e85c-4dbf-8722-cd2f8e0f5d1a | 2026-07-20 | Warnings, Adverse reactions | 207099 ANDA207099 |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | 2bc65375-77b8-1e50-e063-6294a90acf8f | 2026-06-26 | Warnings, Adverse reactions | 207099 ANDA207099 |
| gabapentin | GABAPENTIN | Proficient Rx LP | c7674ea5-276b-4bb3-821b-4ac05c9e64e6 | 2026-06-01 | Warnings, Adverse reactions | 207099 ANDA207099 |
| Gabapentin | GABAPENTIN | Direct_Rx | 0b286fd1-8179-d87a-e063-6294a90a2f23 | 2026-03-05 | Warnings, Adverse reactions | 207099 ANDA207099 |
| gabapentin | GABAPENTIN | Coupler LLC | 47cd25f6-e123-9aaf-e063-6394a90aeedd | 2026-01-07 | Warnings, Adverse reactions | 207099 ANDA207099 |
| gabapentin | GABAPENTIN | Northwind Health Company, LLC | 471b2d32-0cbd-aade-e063-6394a90a1696 | 2025-12-29 | Warnings, Adverse reactions | 207099 ANDA207099 |
| gabapentin | GABAPENTIN | REMEDYREPACK INC. | 4a975ebe-ae0a-446a-8a3d-2ca325e28f93 | 2025-09-22 | Warnings, Adverse reactions | 207099 ANDA207099 |
| gabapentin | GABAPENTIN | Coupler LLC | 3eeda97d-c3cd-65cd-e063-6394a90aae8b | 2025-09-16 | Warnings, Adverse reactions | 207099 ANDA207099 |
| Gabapentin | GABAPENTIN | Direct_Rx | 2cb1ad6d-d389-4564-e063-6394a90a3644 | 2025-08-19 | Warnings, Adverse reactions | 207099 ANDA207099 |
| gabapentin | GABAPENTIN | Rising Pharma Holdings, Inc. | 969cccfc-e56a-49da-9d36-47c0c3fad7f8 | 2025-06-03 | Warnings, Adverse reactions | 207099 ANDA207099 |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 64a65366-8577-48f2-9f8e-0332f126d3c1 | 2025-03-01 | Warnings, Adverse reactions | 207099 ANDA207099 |
| Gabapentin | GABAPENTIN | Epic Pharma, LLC | 030e656a-e384-49ac-830f-32140c18112d | 2019-01-07 | Warnings, Adverse reactions | 207099 ANDA207099 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58657-720-50 | 58657072050 | 500 CAPSULE in 1 BOTTLE (58657-720-50) | 500 capsule | 2017-03-24 | 2022-12-31 | No | No | Current |