gabapentin
- Product NDC
- 68382-357
- 11-digit product format
- 683820357
- Labeler code
- 68382
- Product ID
- 68382-357_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
- 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
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 |
|---|
| 68382-357-01 | 68382035701 | 100 TABLET in 1 BOTTLE (68382-357-01) | 100 tablet | 2025-09-18 | No | No | Historical |
| 68382-357-14 | 68382035714 | 60 TABLET in 1 BOTTLE (68382-357-14) | 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 |