Topiramate
- Product NDC
- 71610-492
- 11-digit product format
- 716100492
- Labeler code
- 71610
- Product ID
- 71610-492_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
- 100 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Topiramate
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| TOPIRAMATE | 100 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 151226, 199888, 199889, 199890 |
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 |
|---|
| 71610-492-30 | 71610049230 | 30 TABLET in 1 BOTTLE (71610-492-30) | 30 tablet | 2020-11-17 | 0000-00-00 | No | No | Current |
| 71610-492-45 | 71610049245 | 45 TABLET in 1 BOTTLE (71610-492-45) | 45 tablet | 2020-11-17 | 0000-00-00 | No | No | Current |
| 71610-492-53 | 71610049253 | 60 TABLET in 1 BOTTLE (71610-492-53) | 60 tablet | 2020-11-17 | 0000-00-00 | No | No | Current |
| 71610-492-60 | 71610049260 | 90 TABLET in 1 BOTTLE (71610-492-60) | 90 tablet | 2020-11-17 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Topiramate | Aphena Pharma Solutions - Tennessee, LLC | 2021-05-03 | HUMAN PRESCRIPTION DRUG LABEL | 2 |