Topiramate
- Product NDC
- 80425-0288
- 11-digit product format
- 804250288
- Labeler code
- 80425
- Product ID
- 80425-0288_2a9bfe6a-6d66-b262-e063-6294a90a1cf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2023-03-22
- Substance
- TOPIRAMATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], 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 |
|---|
| 0H73WJJ391 | TOPIRAMATE | 97240-79-4 | TOPIRAMATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0288-1 | 80425028801 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0288-1) | 2023-03-22 | No | No | Historical |
| 80425-0288-2 | 80425028802 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0288-2) | 2023-03-22 | No | No | Historical |
| 80425-0288-3 | 80425028803 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0288-3) | 2023-03-22 | No | No | Historical |
| 80425-0288-4 | 80425028804 | 270 TABLET, FILM COATED in 1 BOTTLE (80425-0288-4) | 2023-08-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Topiramate Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 3 |