gabapentin
- Product NDC
- 68382-356
- 11-digit product format
- 683820356
- Labeler code
- 68382
- Product ID
- 68382-356_898c1710-d86c-4fbe-9a53-34661fcdb63a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA203934
- Marketing category
- ANDA
- Marketing start
- 2025-09-18
- Substance
- GABAPENTIN
- Active strength
- 750 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
openFDA Listing Details
- Product ID
- 68382-356_898c1710-d86c-4fbe-9a53-34661fcdb63a
- SPL ID
- 898c1710-d86c-4fbe-9a53-34661fcdb63a
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- gabapentin
- Generic name
- gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2025-09-18
- Marketing category
- ANDA
- Application number
- ANDA203934
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| GABAPENTIN | 750 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 1806380, 1806382, 2634743, 2634747, 2634751 |
| Spl Set Id | 3cfd04ab-e421-441f-a10e-e4dd1412974d |
| Manufacturer Name | Zydus Pharmaceuticals USA Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 68382-356-01 | 100 TABLET in 1 BOTTLE (68382-356-01) | 2025-09-18 | No |
| 68382-356-14 | 60 TABLET in 1 BOTTLE (68382-356-14) | 2025-09-18 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6CW7F3G59X | GABAPENTIN | 60142-96-3 | GABAPENTIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-356-01 | 68382035601 | 100 TABLET in 1 BOTTLE (68382-356-01) | 100 tablet | 2025-09-18 | No | No | Historical |
| 68382-356-14 | 68382035614 | 60 TABLET in 1 BOTTLE (68382-356-14) | 60 tablet | 2025-09-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| gabapentin | Zydus Pharmaceuticals USA Inc. | 2025-09-05 | HUMAN PRESCRIPTION DRUG LABEL | 3 |