Gabapentin
- Product NDC
- 68788-7847
- Requested package NDC
- 68788-7847-9
- 11-digit product format
- 687887847
- Labeler code
- 68788
- Product ID
- 68788-7847_79a177b5-7d19-430b-99e3-14ff7b66dc34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA205101
- Marketing category
- ANDA
- Marketing start
- 2021-01-21
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 600 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 | 68788-7847 | 68788-7847-9 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205101-001 | GABAPENTIN | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | |
| A205101-002 | GABAPENTIN | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205101-001 | AB1 |
| A205101-002 | AB1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2016-02-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2016-02-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2016-02-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2016-02-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2016-02-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2016-02-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2016-02-04 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2016-02-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2016-02-04 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2016-02-04 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205101-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205101-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205101-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205101-002 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205101-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205101-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205101-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205101-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205101-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205101-002 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205101-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205101-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205101-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205101-002 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205101-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205101-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205101-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205101-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205101-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205101-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205101-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205101-002 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205101-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205101-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205101-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205101-002 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205101-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205101-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205101-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A205101-002 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205101-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205101-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205101-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205101-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205101-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205101-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205101-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205101-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A205101-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205101-002 | AB | 1 | bb7c543d1eb4… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7847-1 | EA - Each | 68788-7847 | 425463a7-104e-4ed8-acaa-d3da05f123d7 | 1 | 2021-03-02 |
| 68788-7847-3 | EA - Each | 68788-7847 | d46bc42a-5a85-4487-a756-8f999b2b1327 | 1 | 2021-03-02 |
| 68788-7847-6 | EA - Each | 68788-7847 | f707f234-38b4-4fdb-b2ff-8fc69514a3c3 | 1 | 2021-03-02 |
| 68788-7847-8 | EA - Each | 68788-7847 | 5c79f1c9-76b9-4f99-ba1a-2a3295beb29c | 1 | 2021-03-02 |
| 68788-7847-9 | EA - Each | 68788-7847 | b50d932d-2e4a-48c0-9641-9135fe86c9d6 | 1 | 2021-03-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7847 | GABAPENTIN TABLET [PREFERRED PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20240531_8cb353e4-ee6b-42d6-beb8-2ed905bd7d6a.zip |
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 | PD-Rx Pharmaceuticals, Inc. | 9b175f8d-7667-4bfe-8bb5-fd7441eed456 | 2026-07-08 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | HAWAII REPACK, INC. | f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c | 2026-07-02 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | ba4d863d-be38-8cf5-e053-2995a90a69fb | 2026-06-26 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | c85ae572-9893-629e-e053-2995a90a23fc | 2026-06-26 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | ce0f0d7f-da6d-47da-a4ed-fb8f72902412 | 2026-04-13 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | abb56036-88df-4720-ba78-529971671545 | 2026-04-13 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | a75c9157-a1fc-44cc-89f8-c5a3742fb9ed | 2026-04-13 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | d1aa4690-57b5-4a3e-ac12-85f777dbd05e | 2026-04-13 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 75caca13-1432-4c0d-8d45-f029b0b2d417 | 2026-03-31 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 56378630-e7a7-4981-8212-8ea703a433d8 | 2026-03-31 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Radha Pharmaceuticals, Inc. | 1045db4e-4c76-4a0d-bf12-019bd96a8f59 | 2026-03-11 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | ScieGen Pharmaceuticals, Inc. | 5ab9c18b-9568-4dcb-90b0-252aef8f8dc2 | 2026-02-20 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals, Inc. | 5d3f27bf-3486-40fa-a4d3-5f0b2c6c0151 | 2025-06-11 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals, Inc. | 561f53d5-5301-42b3-b372-f3d49d642a2e | 2025-06-11 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Coupler LLC | 3133fc78-dd7a-880c-e063-6394a90a89e1 | 2025-03-25 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Directrx | d5c9dd2c-b8ee-1406-e053-2995a90a0287 | 2025-01-21 | Adverse reactions | 205101 ANDA205101 |
| GABAPENTIN | GABAPENTIN | DIRECT RX | a7e45e3f-e382-32ba-e053-2a95a90a2537 | 2025-01-17 | 205101 ANDA205101 | |
| Gabapentin | GABAPENTIN | Creekwood Pharmaceuticals LLC | 266ef369-0a56-f225-e063-6294a90a495e | 2024-09-01 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | a9c99dfa-f54d-9207-e053-2995a90ad43b | 2024-07-17 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | a9f0852e-0c58-ba22-e053-2995a90adfa0 | 2024-07-17 | Warnings, Adverse reactions | 205101 ANDA205101 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-7847-9 | 68788784709 | 90 TABLET in 1 BOTTLE (68788-7847-9) | 90 tablet | 2021-01-21 | 0000-00-00 | No | No | Current |