Gabapentin
- Product NDC
- 21695-055
- 11-digit product format
- 216950055
- Labeler code
- 21695
- Product ID
- 21695-055_6f3e6391-e711-42bd-9d95-ce15d7a44ed5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA075360
- Marketing category
- ANDA
- Marketing start
- 2009-09-24
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 21695-055 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 21695-055 | 21695-055-00 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 21695-055 | 21695-055-30 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 21695-055 | 21695-055-60 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 21695-055 | 21695-055-90 | I | Inactivated by FDA | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075360-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | |
| A075360-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | |
| A075360-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075360-001 | AB |
| A075360-002 | AB |
| A075360-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-10-29 15:01 UTC | 2024-10 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 8869cabd3fbd… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-10-29 15:01 UTC | 2024-10 | A075360-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075360-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075360-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075360-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075360-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075360-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075360-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075360-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075360-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075360-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075360-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075360-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075360-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075360-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075360-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075360-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075360-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075360-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075360-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075360-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075360-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075360-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075360-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075360-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075360-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075360-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075360-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075360-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075360-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075360-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075360-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075360-001 | AB | 1 | 8869cabd3fbd… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | c681c804-c6f3-d63b-e053-2995a90a6b8f | 2026-06-17 | Warnings, Adverse reactions | 075360 ANDA075360 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 397fd6d3-317b-4b61-a52b-3a09ca1d88a4 | 2026-05-22 | Warnings, Adverse reactions | 075360 ANDA075360 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 13640281-26b4-402e-8f69-7c81cd6e0376 | 2026-05-22 | Warnings, Adverse reactions | 075360 ANDA075360 |
| GABAPENTIN | GABAPENTIN | ST. MARY'S MEDICAL PARK PHARMACY | 3aaf3d6e-c6d5-89f5-e063-6394a90a9b77 | 2025-12-29 | Warnings, Adverse reactions | 075360 ANDA075360 |
| GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | b20ee34a-7f2d-4d62-a161-898565f74547 | 2025-12-02 | Warnings, Adverse reactions | 075360 ANDA075360 |
| Gabapentin | GABAPENTIN | Advanced Rx Pharmacy of Tennessee, LLC | c859e666-d510-426b-e053-2995a90a9a3c | 2024-12-31 | Warnings, Adverse reactions | 075360 ANDA075360 |
| GABAPENTIN | GABAPENTIN | Asclemed USA, Inc. | 5fb79774-c2d4-47ba-9a16-eb367d0fdcff | 2023-09-30 | Warnings, Adverse reactions | 075360 ANDA075360 |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | aa3ab216-372a-4a72-bfd1-88a1ffa31ba3 | 2022-05-01 | Warnings, Adverse reactions | 075360 ANDA075360 |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | 185f264e-db32-41cd-b90d-519717b97850 | 2021-11-01 | Warnings, Adverse reactions | 075360 ANDA075360 |
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 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-055-00 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ccb-48b1-e053-8cdaa90a720a | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 |
| 21695-055-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ccb-48b1-e053-8cdaa90a720a | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 |
| 21695-055-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ccb-48b1-e053-8cdaa90a720a | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 |
| 21695-055-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ccb-48b1-e053-8cdaa90a720a | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-055-00 | Gabapentin | 100 in 1 BOTTLE | CAPSULE | 100 | 1 | |
| 21695-055-30 | Gabapentin | 30 in 1 BOTTLE | CAPSULE | 30 | 1 | |
| 21695-055-60 | Gabapentin | 60 in 1 BOTTLE | CAPSULE | 60 | 1 | |
| 21695-055-90 | Gabapentin | 90 in 1 BOTTLE | CAPSULE | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-055-00 | EA - Each | 21695-055 | 6816814e-2d64-4410-a8c7-9f696c768dc7 | 1 | 2012-07-24 |
| 21695-055-30 | EA - Each | 21695-055 | 8264ff43-fea1-4952-84d0-098dc567ce1b | 1 | 2012-07-24 |
| 21695-055-60 | EA - Each | 21695-055 | 0ab2ad2a-c886-4f8f-8573-b8b6d31a59d5 | 1 | 2012-07-24 |
| 21695-055-90 | EA - Each | 21695-055 | 03f12230-bc83-4e02-9bfa-a4c5db4be605 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310430 | gabapentin 100 MG Oral Capsule | PSN | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 | 1 |
| 310431 | gabapentin 300 MG Oral Capsule | PSN | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 | 1 |
| 310432 | gabapentin 400 MG Oral Capsule | PSN | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 | 1 |
| 310430 | gabapentin 100 MG Oral Capsule | SCD | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 | 1 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 | 1 |
| 310432 | gabapentin 400 MG Oral Capsule | SCD | 237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-055-00 | 21695005500 | 100 in 1 BOTTLE | Historical |
| 21695-055-30 | 21695005530 | 30 in 1 BOTTLE | Historical |
| 21695-055-60 | 21695005560 | 60 in 1 BOTTLE | Historical |
| 21695-055-90 | 21695005590 | 90 in 1 BOTTLE | Historical |