GABAPENTIN
- Product NDC
- 58657-620
- Requested package NDC
- 58657-620-01
- 11-digit product format
- 586570620
- Labeler code
- 58657
- Product ID
- 58657-620_aedea5a7-821d-4ddd-a977-c4c576cdfb04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA204989
- Marketing category
- ANDA
- Marketing start
- 2016-09-30
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- 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 | 58657-620 | 58657-620-01 | D | Discontinued by firm | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|---|
| A204989-001 | RELGAABI | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | |
| A204989-002 | RELGAABI | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | |
| A204989-003 | RELGAABI | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | |
| A204989-004 | RELGAABI | GABAPENTIN | 200MG | CAPSULE / ORAL | AB | 2026-03-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204989-001 | AB |
| A204989-002 | AB |
| A204989-003 | AB |
| A204989-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204989-001 | RELGAABI | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204989-002 | RELGAABI | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204989-003 | RELGAABI | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204989-004 | RELGAABI | 200MG | CAPSULE / ORAL | AB | 2026-03-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-001 | RELGAABI | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-002 | RELGAABI | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-003 | RELGAABI | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-004 | RELGAABI | 200MG | CAPSULE / ORAL | AB | 2026-03-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204989-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204989-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204989-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204989-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-002 | AB | 1 | 79d66fd596c7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-620-01 | EA - Each | 58657-620 | 50df30c0-644f-4202-9bc5-d58df5b9d160 | 1 | 2017-03-06 |
| 58657-620-50 | EA - Each | 58657-620 | 61f8a4b4-417a-4252-be57-afc102899a04 | 1 | 2017-03-06 |
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 | NuCare Pharmaceuticals,Inc. | d35cd5ac-5ed6-2405-e053-2995a90a6946 | 2026-09-03 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 1af098ad-28b5-463f-8efa-24d70a77d64c | 2026-08-26 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 9a2658d5-9b0e-4921-b4c5-4c89f1630d69 | 2026-08-26 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 43cbff48-8219-41ba-b67d-3ae4544b78bb | 2026-08-26 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Trifluent Pharma, LLC | 59442de1-7cf0-35f6-e063-6294a90a57d7 | 2026-08-17 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | cb81fd89-b32b-4538-bf5c-ab02f65b3458 | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 691205ba-fa65-4bc9-ba20-7d361382cff9 | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 97e47698-97c9-4eb5-a108-5850c2aa2818 | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 2ac0622c-440a-49a0-974f-726e6ac72a0e | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 48037fc4-1aab-4ae8-aede-7c55b494877a | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | e877a425-2b7f-4e43-a1f9-24019cbf9685 | 2026-07-31 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | ScieGen Pharmaceuticals, Inc. | 16542ee6-0e0e-4d3c-8b32-60ff6ef48846 | 2026-07-21 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | 4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a | 2026-07-17 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | HAWAII REPACK, INC. | dd7adad2-e2f5-4b43-90a4-522bce0be5b3 | 2026-07-02 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Northwind Health Company, LLC | 1b44a3ab-4d06-205f-e063-6294a90af368 | 2026-06-22 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Asclemed USA, Inc. | 9a829dc3-b2d8-4d19-a579-0597217cec9b | 2026-06-17 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | b7a29b99-ce23-950e-e053-2995a90a1934 | 2026-06-09 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 4c49d34d-bb47-406b-8f2d-b4834b2ee9d0 | 2026-06-08 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Coupler LLC | 5385e27c-f2fa-32d5-e063-6294a90a0a8c | 2026-06-05 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Direct_Rx | f8998c1c-c359-6f01-e053-6294a90aebf4 | 2026-06-01 | Warnings, Adverse reactions | 204989 ANDA204989 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58657-620-01 | 58657062001 | 100 CAPSULE in 1 BOTTLE (58657-620-01) | 100 capsule | 2016-09-30 | 0000-00-00 | No | No | Current |