Topiramate
- Product NDC
- 50090-6828
- 11-digit product format
- 500906828
- Labeler code
- 50090
- Product ID
- 50090-6828_9a51725c-affe-4ebf-bc2f-853a2817561c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2014-06-12
- Substance
- TOPIRAMATE
- Active strength
- 50 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6828-0 | 50090682800 | 90 TABLET in 1 BOTTLE (50090-6828-0) | 90 tablet | 2023-11-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Topiramate | A-S Medication Solutions | 2025-04-29 | HUMAN PRESCRIPTION DRUG LABEL | 3 |