Gabapentin
- Product NDC
- 67877-428
- 11-digit product format
- 678770428
- Labeler code
- 67877
- Product ID
- 67877-428_280c139f-c3a2-46e4-b990-ce3808166e86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA206402
- Marketing category
- ANDA
- Marketing start
- 2015-11-01
- Substance
- GABAPENTIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206402-001 | GABAPENTIN | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | |
| A206402-002 | GABAPENTIN | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206402-001 | AB1 |
| A206402-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2015-12-23 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2015-12-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2015-12-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2015-12-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2015-12-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2015-12-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2015-12-23 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2015-12-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2015-12-23 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2015-12-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2015-12-23 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2015-12-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206402-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2015-12-23 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206402-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2015-12-23 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206402-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206402-002 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206402-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206402-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206402-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206402-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206402-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206402-002 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206402-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206402-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206402-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206402-002 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206402-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206402-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206402-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206402-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206402-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206402-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206402-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206402-002 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206402-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206402-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206402-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206402-002 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206402-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206402-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206402-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A206402-002 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206402-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206402-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206402-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A206402-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206402-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A206402-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206402-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206402-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206402-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A206402-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206402-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A206402-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gabapentin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GABAPENTIN | 600 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6CW7F3G59X | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cdc2ae60-922e-452d-a42f-787fe4e2ed06 | Product name | 1 | 20250123 |
| 7059096a-4b9f-36c2-db50-bb5c723e6e9e | Product name | 2 | 20250114 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67877-428-01 | Gabapentin | 100 in 1 BOTTLE | TABLET | 100 | 30 | |
| 67877-428-05 | Gabapentin | 500 in 1 BOTTLE | TABLET | 500 | 30 | |
| 67877-428-10 | Gabapentin | 1000 in 1 BOTTLE | TABLET | 1000 | 30 | |
| 67877-428-38 | Gabapentin | 10 in 1 BLISTER PACK | TABLET | 10 | 30 | |
| 67877-428-38 | Gabapentin | 100 in 1 CARTON | TABLET | 100 | 30 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67877-428-01 | EA - Each | 67877-428 | 345d2f1d-eca8-4bd1-ad15-74ae9e0a04ac | 1 | 2016-11-08 |
| 67877-428-05 | EA - Each | 67877-428 | 6ec154a4-de7d-4e30-b9fa-04414f8d769b | 1 | 2016-11-08 |
DailyMed Dashboard NDC Coverage#
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. | 81243958-cc5a-4ec0-a64d-71682f949d5f | 2026-07-30 | Warnings, Adverse reactions | 206402 ANDA206402 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | bc525ae4-9843-4038-a1b7-0d3543e2282c | 2026-07-30 | Warnings, Adverse reactions | 206402 ANDA206402 |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals, Inc. | 57383d2a-d2c7-bbdc-e063-6294a90ada98 | 2026-07-22 | Warnings, Adverse reactions | 206402 ANDA206402 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 172776c0-909e-49ce-bfe1-cf154a9458ba | 2026-07-15 | Warnings, Adverse reactions | 206402 ANDA206402 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | df9c7c84-a8d9-4da8-babe-c55c9420d4e6 | 2026-07-15 | Warnings, Adverse reactions | 206402 ANDA206402 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 72729513-bd34-44f5-9f62-297ed25c4442 | 2026-07-15 | Warnings, Adverse reactions | 206402 ANDA206402 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | f31172a2-0ae9-49f2-b797-b26fe33f3f64 | 2026-07-15 | Warnings, Adverse reactions | 206402 ANDA206402 |
| Gabapentin | GABAPENTIN | Ascend Laboratories, LLC | 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a | 2026-06-04 | Warnings, Adverse reactions | 206402 ANDA206402 67877-428 |
| Gabapentin | GABAPENTIN | Direct_Rx | 30a2ed14-dcda-f972-e063-6294a90a417c | 2025-04-23 | Warnings, Adverse reactions | 206402 ANDA206402 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | a1ff94a9-69c4-486a-aab2-563c7ed244c8 | 2025-01-30 | Warnings, Adverse reactions | 206402 ANDA206402 |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | afa28969-91ca-83fd-e053-2a95a90a656b | 2024-12-31 | Warnings, Adverse reactions | 206402 ANDA206402 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67877-428-01 | 67877042801 | 100 TABLET in 1 BOTTLE (67877-428-01) | 100 tablet | 2015-11-01 | 0000-00-00 | No | No | Current |
| 67877-428-05 | 67877042805 | 500 TABLET in 1 BOTTLE (67877-428-05) | 500 tablet | 2015-11-01 | 0000-00-00 | No | No | Current |
| 67877-428-10 | 67877042810 | 1000 TABLET in 1 BOTTLE (67877-428-10) | 1000 tablet | 2015-11-01 | 0000-00-00 | No | No | Current |
| 67877-428-38 | 67877042838 | 100 BLISTER PACK in 1 CARTON (67877-428-38) / 10 TABLET in 1 BLISTER PACK | 100 blister pack | 2015-11-01 | 0000-00-00 | No | No | Current |