Gabapentin
- Product NDC
- 0904-5632
- 11-digit product format
- 009045632
- Labeler code
- 0904
- Product ID
- 0904-5632_d2dd7fa1-6756-474d-8eb9-10efed51dfdf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075360
- Marketing category
- ANDA
- Marketing start
- 2005-04-06
- Marketing end
- 2019-06-30
- Substance
- GABAPENTIN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 0904-5632 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 0904-5632 | 0904-5632-61 | D | Discontinued by firm | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075360-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075360-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075360-003 | AB | 1 | a50c72e98297… |
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5632-40 | EA - Each | 0904-5632 | e6762a19-f27b-45af-960d-ab586de226ef | 1 | 2013-02-13 |
| 0904-5632-46 | EA - Each | 0904-5632 | 251ef99b-2f7a-488a-9873-f8f82415340b | 1 | 2013-02-13 |
| 0904-5632-52 | EA - Each | 0904-5632 | 40f57631-60da-4527-9361-3175207899ad | 1 | 2013-02-13 |
| 0904-5632-53 | EA - Each | 0904-5632 | 969c40ad-ec9d-4776-8d89-7c1701d181bd | 1 | 2013-02-13 |
| 0904-5632-61 | EA - Each | 0904-5632 | b111c402-8e58-45c9-bad3-2c8096b307dd | 1 | 2013-08-02 |
| 0904-5632-89 | EA - Each | 0904-5632 | 18ab6fac-42d1-456b-b5bf-2a9631dab6cb | 1 | 2013-02-13 |
| 0904-5632-93 | EA - Each | 0904-5632 | 5e203c40-b869-493c-842a-d8e415e12e79 | 1 | 2013-02-13 |