topiramate
- Product NDC
- 60760-075
- 11-digit product format
- 607600075
- Labeler code
- 60760
- Product ID
- 60760-075_3cd0de0b-c112-1b86-e063-6294a90af536
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2019-09-05
- 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 |
|---|
| 60760-075-30 | 60760007530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-075-30) | 2025-08-20 | No | No | Historical |
| 60760-075-60 | 60760007560 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-075-60) | 2019-09-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| topiramate | ST. MARY'S MEDICAL PARK PHARMACY | 2025-08-20 | HUMAN PRESCRIPTION DRUG LABEL | 4 |