Gabapentin
- Product NDC
- 80425-0204
- 11-digit product format
- 804250204
- Labeler code
- 80425
- Product ID
- 80425-0204_2a99e9e8-3d19-ee0b-e063-6294a90ae4ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA207057
- Marketing category
- ANDA
- Marketing start
- 2022-10-28
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0204-1 | 80425020401 | 30 TABLET, COATED in 1 BOTTLE (80425-0204-1) | 2023-11-01 | No | No | Historical |
| 80425-0204-2 | 80425020402 | 60 TABLET, COATED in 1 BOTTLE (80425-0204-2) | 2023-11-01 | No | No | Historical |
| 80425-0204-3 | 80425020403 | 90 TABLET, COATED in 1 BOTTLE (80425-0204-3) | 2023-11-01 | No | No | Historical |
| 80425-0204-4 | 80425020404 | 120 TABLET, COATED in 1 BOTTLE (80425-0204-4) | 2023-11-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin Tablets | Advanced Rx of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 9 |