topiramate
- Product NDC
- 50090-7067
- 11-digit product format
- 500907067
- Labeler code
- 50090
- Product ID
- 50090-7067_2216e3a9-4aa1-415e-acfe-f0877be8842c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- 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 |
|---|
| 50090-7067-0 | 50090706700 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7067-0) | 2024-01-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| topiramate | A-S Medication Solutions | 2024-08-21 | HUMAN PRESCRIPTION DRUG LABEL | 1 |