gabapentin
- Product NDC
- 70771-1918
- 11-digit product format
- 707711918
- Labeler code
- 70771
- Product ID
- 70771-1918_ba40713a-2f22-4276-a664-355e7442cda4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA203934
- Marketing category
- ANDA
- Marketing start
- 2025-09-18
- Substance
- GABAPENTIN
- Active strength
- 900 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- gabapentin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GABAPENTIN | 900 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6CW7F3G59X |
| Rxcui | 1806380, 1806382, 2634743, 2634747, 2634751 |
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 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70771-1918-1 | gabapentin | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 70771-1918-6 | gabapentin | 60 in 1 BOTTLE | TABLET | 60 | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1806380 | gabapentin 300 MG Once-Daily Oral Tablet | PSN | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 2634747 | gabapentin 450 MG Once-Daily Oral Tablet | PSN | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 1806382 | gabapentin 600 MG Once-Daily Oral Tablet | PSN | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 2634751 | gabapentin 750 MG Once-Daily Oral Tablet | PSN | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 2634743 | gabapentin 900 MG Once-Daily Oral Tablet | PSN | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 1806380 | Once-Daily gabapentin 300 MG Oral Tablet | SCD | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 2634747 | Once-Daily gabapentin 450 MG Oral Tablet | SCD | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 1806382 | Once-Daily gabapentin 600 MG Oral Tablet | SCD | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 2634751 | Once-Daily gabapentin 750 MG Oral Tablet | SCD | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 2634743 | Once-Daily gabapentin 900 MG Oral Tablet | SCD | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 1806380 | gabapentin 300 MG Once-Daily Oral Tablet | SY | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 2634747 | gabapentin 450 MG Once-Daily Oral Tablet | SY | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 1806382 | gabapentin 600 MG Once-Daily Oral Tablet | SY | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 2634751 | gabapentin 750 MG Once-Daily Oral Tablet | SY | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
| 2634743 | gabapentin 900 MG Once-Daily Oral Tablet | SY | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70771-1918-1 | 70771191801 | 100 TABLET in 1 BOTTLE (70771-1918-1) | 100 tablet | 2025-09-18 | No | No | Historical |
| 70771-1918-6 | 70771191806 | 60 TABLET in 1 BOTTLE (70771-1918-6) | 60 tablet | 2025-09-18 | No | No | Historical |