topiramate
- Product NDC
- 68788-8828
- 11-digit product format
- 687888828
- Labeler code
- 68788
- Product ID
- 68788-8828_288d6b40-8c87-4f16-85a7-86166b5ac77f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2025-02-14
- 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
openFDA Listing Details
- Product ID
- 68788-8828_288d6b40-8c87-4f16-85a7-86166b5ac77f
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- topiramate
- Generic name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2025-02-14
- Marketing category
- ANDA
- Application number
- ANDA090162
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA]; Cytochrome P450 3A4 Inducers [MoA]; Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| TOPIRAMATE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 151226 |
| Spl Set Id | 288d6b40-8c87-4f16-85a7-86166b5ac77f |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
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 |
|---|
| 68788-8828-1 | 68788882801 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8828-1) | 2025-02-14 | No | No | Current |
| 68788-8828-3 | 68788882803 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8828-3) | 2025-02-14 | No | No | Current |
| 68788-8828-5 | 68788882805 | 15 TABLET, FILM COATED in 1 BOTTLE (68788-8828-5) | 2025-02-14 | No | No | Current |
| 68788-8828-6 | 68788882806 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8828-6) | 2025-02-14 | No | No | Current |
| 68788-8828-9 | 68788882809 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8828-9) | 2025-02-14 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| topiramate | Preferred Pharmaceuticals Inc. | 2025-02-14 | HUMAN PRESCRIPTION DRUG LABEL | 1 |