Gabapentin
- Product NDC
- 71610-778
- 11-digit product format
- 716100778
- Labeler code
- 71610
- Product ID
- 71610-778_2e79999c-5c38-42c2-bd3a-91286ab18ed5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA205101
- Marketing category
- ANDA
- Marketing start
- 2023-11-03
- Substance
- GABAPENTIN
- Active strength
- 800 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 |
|---|
| 71610-778-45 | 71610077845 | 45 TABLET in 1 BOTTLE (71610-778-45) | 45 tablet | 2024-01-25 | No | No | Historical |
| 71610-778-53 | 71610077853 | 60 TABLET in 1 BOTTLE (71610-778-53) | 60 tablet | 2024-01-31 | No | No | Historical |
| 71610-778-70 | 71610077870 | 120 TABLET in 1 BOTTLE (71610-778-70) | 120 tablet | 2024-01-25 | No | No | Historical |
| 71610-778-92 | 71610077892 | 270 TABLET in 1 BOTTLE (71610-778-92) | 270 tablet | 2024-01-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | 2024-01-31 | HUMAN PRESCRIPTION DRUG LABEL | 1 |