topiramate
- Product NDC
- 72162-2481
- 11-digit product format
- 721622481
- Labeler code
- 72162
- Product ID
- 72162-2481_34196b1d-b814-d2bf-e063-6294a90a2f17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2481-0 | 72162248100 | 1000 TABLET, FILM COATED in 1 BOTTLE (72162-2481-0) | 2025-05-01 | No | No | Historical |
| 72162-2481-5 | 72162248105 | 500 TABLET, FILM COATED in 1 BOTTLE (72162-2481-5) | 2025-05-01 | No | No | Historical |
| 72162-2481-6 | 72162248106 | 60 TABLET, FILM COATED in 1 BOTTLE (72162-2481-6) | 2025-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| topiramate | Bryant Ranch Prepack | 2025-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 101 |