GABAPENTIN
- Product NDC
- 31722-149
- 11-digit product format
- 317220149
- Labeler code
- 31722
- Product ID
- 31722-149_2a2c08de-b06c-4926-e063-6394a90a2eb0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA214956
- Marketing category
- ANDA
- Marketing start
- 2021-05-10
- Substance
- GABAPENTIN
- Active strength
- 300 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 |
|---|---|---|---|---|---|---|---|
| A214956-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | |
| A214956-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | |
| A214956-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214956-001 | AB |
| A214956-002 | AB |
| A214956-003 | 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 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214956-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2021-05-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214956-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2021-05-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A214956-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2021-05-10 | 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 | A214956-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214956-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214956-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214956-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214956-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214956-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214956-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214956-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214956-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214956-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214956-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214956-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214956-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214956-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214956-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214956-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214956-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214956-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214956-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214956-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214956-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214956-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214956-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214956-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214956-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214956-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214956-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214956-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214956-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214956-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214956-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214956-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214956-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214956-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214956-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214956-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214956-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214956-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214956-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214956-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GABAPENTIN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GABAPENTIN | 300 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6CW7F3G59X | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b | 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 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 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 |
|---|---|---|---|---|---|---|
| 31722-149-01 | GABAPENTIN | 100 in 1 BOTTLE | CAPSULE | 100 | 3 | |
| 31722-149-05 | GABAPENTIN | 500 in 1 BOTTLE | CAPSULE | 500 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-149-01 | EA - Each | 31722-149 | 53a40232-31e1-4173-bf0f-4f08e0c9324f | 1 | 2021-12-08 |
| 31722-149-05 | EA - Each | 31722-149 | 2a76849d-ae0a-403d-8534-a3d53f55abef | 1 | 2021-12-08 |
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 | St. Mary's Medical Park Pharmacy | 235a6954-318a-9e3a-e063-6394a90a0e21 | 2026-06-19 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | dd0e12c2-1986-4ca3-a809-d703a7542419 | 2026-04-22 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | A-S Medication Solutions | 4aa69d04-6b32-4764-a48b-ef5313dd95d3 | 2026-01-23 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | A-S Medication Solutions | 43a3ec78-8235-4d46-a343-2f9226745a39 | 2026-01-23 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | A-S Medication Solutions | 685553b0-384e-400b-a8ae-612ceece8261 | 2026-01-22 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | A-S Medication Solutions | 7ea0b220-edbb-45eb-aeb3-65283f8489a1 | 2026-01-22 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | Northwind Health Company, LLC | 47214c7c-ba1b-9107-e063-6294a90a5431 | 2025-12-29 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | Redpharm Drug | 44f2b497-55b2-864f-e063-6294a90ad6d5 | 2025-12-02 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | REMEDYREPACK INC. | fbeccab7-08aa-4da3-868f-b47a1f3d41ef | 2025-10-08 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | XLCare Pharmaceuticals, Inc. | 618c948d-deee-44e2-98f0-e5232171dd50 | 2025-08-04 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals, Inc. | 200b61d7-6e4c-923d-e063-6294a90a42cf | 2025-02-21 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 35ac6b11-7b1c-47a0-a4ba-c193a0bb5b01 | 2025-02-20 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | 2b395a14-0f8e-7f5b-e063-6294a90ab546 | 2025-01-08 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | Camber Pharmaceuticals, Inc. | e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b | 2024-12-26 | Warnings, Adverse reactions | 214956 ANDA214956 31722-149 |
| GABAPENTIN | GABAPENTIN | Asclemed USA, Inc. | 17a62334-209d-4dc1-867a-e5780196a2ca | 2024-11-05 | Warnings, Adverse reactions | 214956 ANDA214956 |
| GABAPENTIN | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | f38098ec-dd1a-405a-bbfb-bad62e4e7fa5 | 2024-01-04 | Warnings, Adverse reactions | 214956 ANDA214956 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 31722-149-01 | 31722014901 | 100 CAPSULE in 1 BOTTLE (31722-149-01) | 100 capsule | 2021-05-10 | 0000-00-00 | No | No | Current |
| 31722-149-05 | 31722014905 | 500 CAPSULE in 1 BOTTLE (31722-149-05) | 500 capsule | 2021-05-10 | 0000-00-00 | No | No | Current |