GABAPENTIN
- Product NDC
- 68788-7135
- Requested package NDC
- 68788-7135-9
- 11-digit product format
- 687887135
- Labeler code
- 68788
- Product ID
- 68788-7135_b5d71771-f1aa-435f-bfaa-68b3288d51cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090007
- Marketing category
- ANDA
- Marketing start
- 2020-06-02
- 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
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 | 68788-7135 | 68788-7135-9 | 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 |
|---|---|---|---|---|---|---|---|
| A090007-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | |
| A090007-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | |
| A090007-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090007-001 | AB |
| A090007-002 | AB |
| A090007-003 | 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 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090007-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2011-07-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090007-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2011-07-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090007-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2011-07-21 | 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 | A090007-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090007-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090007-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090007-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090007-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090007-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090007-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090007-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090007-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090007-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090007-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090007-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090007-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090007-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090007-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090007-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090007-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090007-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090007-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090007-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090007-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090007-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090007-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090007-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090007-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090007-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090007-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090007-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090007-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090007-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090007-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090007-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090007-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090007-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090007-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090007-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090007-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090007-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090007-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090007-001 | 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 | TIME CAP LABORATORIES, INC | 08880902-bd44-41b6-866b-2cbad4c3f2b1 | 2026-07-30 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | 9814b76c-87c6-4746-b712-3269352a901b | 2026-02-16 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | REMEDYREPACK INC. | 915cee37-536c-4761-bdb9-b96c7ee0f956 | 2026-02-13 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | DIRECT RX | 29a70e2d-d3fd-4e32-95dd-7ee721d87388 | 2026-01-08 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | MARKSANS PHARMA LIMITED | 98bb408d-c402-4da6-8f9d-5de4833dedc4 | 2025-09-12 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | 11645bd6-7cfe-49b2-9292-2e4b0dbb84ae | 2025-06-04 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | DIRECT RX | a7e45e3f-e382-32ba-e053-2a95a90a2537 | 2025-01-17 | 090007 ANDA090007 | |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | b062f12c-a745-76d4-e053-2a95a90a3a1a | 2024-12-31 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | c33c4d83-cc13-4104-9e24-d4cd40b17b70 | 2024-10-31 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | e2d9bd8c-3bb9-4945-8e61-7d2703d9008c | 2024-10-31 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 5769d849-4f27-4701-97ec-7e3ca07339d7 | 2024-10-31 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 78088f6a-06a3-422f-b336-4a57a24adc16 | 2024-10-30 | Warnings, Adverse reactions | 090007 ANDA090007 |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | 8f785189-bf66-36cc-e053-2a95a90a7cbc | 2024-06-19 | 090007 ANDA090007 | |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | 82c0ed15-9132-657d-e053-2991aa0ae90a | 2024-06-14 | 090007 ANDA090007 | |
| GABAPENTIN | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 9d1b9121-c25a-4d28-91c5-5fc72f1167f4 | 2018-07-12 | 090007 ANDA090007 | |
| Gabapentin | GABAPENTIN | Bi-Coastal Pharma International LLC | e0cd96d1-b1ef-46ec-a5a3-9505b0811b8b | 2016-04-17 | Warnings, Adverse reactions | 090007 ANDA090007 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-7135-9 | 68788713509 | 90 CAPSULE in 1 BOTTLE (68788-7135-9) | 90 capsule | 2020-06-02 | 0000-00-00 | No | No | Current |