GABAPENTIN
- Product NDC
- 69097-813
- Requested package NDC
- 69097-813-12
- 11-digit product format
- 690970813
- Labeler code
- 69097
- Product ID
- 69097-813_fdeea2da-e306-45d8-a27a-e8be090319ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA090705
- Marketing category
- ANDA
- Marketing start
- 2016-06-29
- Substance
- GABAPENTIN
- Active strength
- 100 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 |
|---|---|---|---|---|---|---|---|
| A090705-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | |
| A090705-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | |
| A090705-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090705-001 | AB |
| A090705-002 | AB |
| A090705-003 | 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 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090705-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2009-12-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090705-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2009-12-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090705-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2009-12-30 | 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 | A090705-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090705-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090705-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090705-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090705-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090705-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090705-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090705-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090705-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090705-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090705-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090705-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090705-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090705-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090705-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090705-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090705-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090705-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090705-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090705-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090705-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090705-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090705-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090705-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090705-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090705-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090705-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090705-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090705-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090705-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090705-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090705-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090705-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090705-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090705-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090705-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090705-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090705-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090705-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090705-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GABAPENTIN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GABAPENTIN | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6CW7F3G59X | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9e4eca9c-6a2c-4ede-a252-1a27094bf594 | 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69097-813-07 | GABAPENTIN | 100 in 1 BOTTLE | CAPSULE | 100 | 8 | |
| 69097-813-12 | GABAPENTIN | 500 in 1 BOTTLE | CAPSULE | 500 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69097-813-07 | EA - Each | 69097-813 | 41918388-50b5-421b-8b9f-d6e7b9a08843 | 1 | 2016-07-19 |
| 69097-813-12 | EA - Each | 69097-813 | d64e3fe7-bba5-49c6-822a-4688c820f10e | 1 | 2016-07-19 |
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. | 1373587e-807a-462a-bff6-8a7113ce9f0a | 2025-10-30 | Warnings, Adverse reactions | 090705 ANDA090705 |
| GABAPENTIN | GABAPENTIN | Exelan Pharmaceuticals, Inc. | 41d1ead3-046e-4abf-ae0a-cb126a1f5848 | 2025-05-01 | Warnings, Adverse reactions | 090705 ANDA090705 |
| GABAPENTIN | GABAPENTIN | Cipla USA Inc. | 9e4eca9c-6a2c-4ede-a252-1a27094bf594 | 2025-05-01 | Warnings, Adverse reactions | 090705 ANDA090705 69097-813-12 69097-813 69097081312 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 6e7f602a-2c5f-4651-a228-5fc5bf249205 | 2024-12-10 | Warnings, Adverse reactions | 090705 ANDA090705 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 1fd95278-842f-4bf9-abd5-4d9aa858d36d | 2024-12-10 | Warnings, Adverse reactions | 090705 ANDA090705 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 97a1d45d-d5b3-4be7-9b3a-cb6f80f60291 | 2024-12-09 | Warnings, Adverse reactions | 090705 ANDA090705 |
| GABAPENTIN | GABAPENTIN | Asclemed USA, Inc. | 45039bba-7a96-450c-95be-83a3aa4fcbd2 | 2020-06-10 | Warnings, Adverse reactions | 090705 ANDA090705 |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | 4bae5032-f634-4d1e-b672-8a7e2bd6a5fa | 2019-11-01 | Warnings, Adverse reactions | 090705 ANDA090705 |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | 92c4d589-533b-4fe4-833f-dd68cc1f7e66 | 2019-11-01 | Warnings, Adverse reactions | 090705 ANDA090705 |
| GABAPENTIN | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | a900bafb-8f49-4a01-ba7f-4fb228ec0253 | 2018-11-12 | Warnings, Adverse reactions | 090705 ANDA090705 |
| GABAPENTIN | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 6702ed8f-4aaf-46fa-bf39-db75154aa44c | 2018-10-19 | Warnings, Adverse reactions | 090705 ANDA090705 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69097-813-12 | 69097081312 | 500 CAPSULE in 1 BOTTLE (69097-813-12) | 500 capsule | 2016-06-29 | 0000-00-00 | No | No | Current |