Topiramate
- Product NDC
- 70518-3460
- 11-digit product format
- 705183460
- Labeler code
- 70518
- Product ID
- 70518-3460_e4b55905-2c2c-7fdf-e053-2a95a90afd45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078462
- Marketing category
- ANDA
- Marketing start
- 2022-07-25
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3460-0 | 70518346000 | 30 POUCH in 1 BOX (70518-3460-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3460-1) | 30 pouch | 2022-07-25 | 0000-00-00 | No | No | Current |