gabapentin
- Product NDC
- 68382-607
- 11-digit product format
- 683820607
- Labeler code
- 68382
- Product ID
- 68382-607_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
- 2024-01-25
- Substance
- GABAPENTIN
- Active strength
- 600 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 |
|---|
| 68382-607-05 | 68382060705 | 500 TABLET in 1 BOTTLE (68382-607-05) | 500 tablet | 2024-01-25 | No | No | Historical |
| 68382-607-16 | 68382060716 | 90 TABLET in 1 BOTTLE (68382-607-16) | 90 tablet | 2024-01-25 | No | No | Historical |
| 68382-607-77 | 68382060777 | 10 BLISTER PACK in 1 CARTON (68382-607-77) / 10 TABLET in 1 BLISTER PACK (68382-607-30) | 10 blister pack | 2024-01-25 | 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 |