Topiramate
- Product NDC
- 71610-493
- 11-digit product format
- 716100493
- Labeler code
- 71610
- Product ID
- 71610-493_875c3303-147e-4bdf-98f2-8355c056e18f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2020-09-07
- Substance
- TOPIRAMATE
- Active strength
- 200 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-493-15 | 71610049315 | 15 TABLET in 1 BOTTLE (71610-493-15) | 15 tablet | 2020-11-17 | No | No | Historical |
| 71610-493-30 | 71610049330 | 30 TABLET in 1 BOTTLE (71610-493-30) | 30 tablet | 2020-11-17 | No | No | Historical |
| 71610-493-60 | 71610049360 | 90 TABLET in 1 BOTTLE (71610-493-60) | 90 tablet | 2020-11-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Topiramate | Aphena Pharma Solutions - Tennessee, LLC | 2021-05-03 | HUMAN PRESCRIPTION DRUG LABEL | 2 |