Topiramate
- Product NDC
- 71205-819
- 11-digit product format
- 712050819
- Labeler code
- 71205
- Product ID
- 71205-819_8bd03bb2-3b9b-4707-a9a4-5618ddc3832f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- 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 |
|---|
| 71205-819-30 | 71205081930 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-819-30) | 2023-07-03 | No | No | Historical |
| 71205-819-60 | 71205081960 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-819-60) | 2023-07-03 | No | No | Historical |
| 71205-819-90 | 71205081990 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-819-90) | 2023-07-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Topiramate | Proficient Rx LP | 2023-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |