Gabapentin
- Product NDC
- 69844-057
- 11-digit product format
- 698440057
- Labeler code
- 69844
- Product ID
- 69844-057_d877a275-3c42-42e4-b83c-19e65403ddcb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Graviti Pharmaceuticals Private Limited
- Application
- ANDA207099
- Marketing category
- ANDA
- Marketing start
- 2017-03-24
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|---|---|
| 69844-057-01 | 69844005701 | 30 CAPSULE in 1 BOTTLE (69844-057-01) | 30 capsule | 2017-03-24 | 0000-00-00 | No | No | Current |
| 69844-057-02 | 69844005702 | 100 CAPSULE in 1 BOTTLE (69844-057-02) | 100 capsule | 2017-03-24 | 0000-00-00 | No | No | Current |
| 69844-057-03 | 69844005703 | 1000 CAPSULE in 1 BOTTLE (69844-057-03) | 1000 capsule | 2017-03-24 | 0000-00-00 | No | No | Current |
| 69844-057-04 | 69844005704 | 500 CAPSULE in 1 BOTTLE (69844-057-04) | 500 capsule | 2017-03-24 | 0000-00-00 | No | No | Current |