GABAPENTIN
- Product NDC
- 62207-922
- 11-digit product format
- 622070922
- Labeler code
- 62207
- Product ID
- 62207-922_b820e737-da30-5009-e053-2a95a90aab2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Granules India Limited
- Application
- ANDA075360
- Marketing category
- ANDA
- Marketing start
- 2020-09-15
- 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
- No
- Listing certified through
- 2022-12-31
- 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 | 62207-922 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 62207-922 | 62207-922-43 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 62207-922 | 62207-922-47 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 62207-922 | 62207-922-49 | 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 Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62207-922-43 | 62207092243 | 100 CAPSULE in 1 BOTTLE (62207-922-43) | 100 capsule | 2020-09-15 | 0000-00-00 | No | No | Current |
| 62207-922-47 | 62207092247 | 500 CAPSULE in 1 BOTTLE (62207-922-47) | 500 capsule | 2020-09-15 | 0000-00-00 | No | No | Current |
| 62207-922-49 | 62207092249 | 1000 CAPSULE in 1 BOTTLE (62207-922-49) | 1000 capsule | 2020-09-15 | 0000-00-00 | No | No | Current |