Gabapentin
- Product NDC
- 80425-0196
- 11-digit product format
- 804250196
- Labeler code
- 80425
- Product ID
- 80425-0196_2a99bd40-3c52-3207-e063-6294a90a4faa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA075477
- Marketing category
- ANDA
- Marketing start
- 2022-10-26
- Substance
- GABAPENTIN
- Active strength
- 300 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 |
|---|
| 80425-0196-1 | 80425019601 | 30 CAPSULE in 1 BOTTLE (80425-0196-1) | 30 capsule | 2023-10-26 | No | No | Historical |
| 80425-0196-2 | 80425019602 | 60 CAPSULE in 1 BOTTLE (80425-0196-2) | 60 capsule | 2023-10-26 | No | No | Historical |
| 80425-0196-3 | 80425019603 | 90 CAPSULE in 1 BOTTLE (80425-0196-3) | 90 capsule | 2023-10-26 | No | No | Historical |
| 80425-0196-4 | 80425019604 | 120 CAPSULE in 1 BOTTLE (80425-0196-4) | 120 capsule | 2023-03-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin Capsules | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 5 |