topiramate
- Product NDC
- 71335-1684
- 11-digit product format
- 713351684
- Labeler code
- 71335
- Product ID
- 71335-1684_97565f5f-1437-4b15-9203-e28fd46d7afc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Substance
- TOPIRAMATE
- Active strength
- 25 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 |
|---|
| 71335-1684-0 | 71335168400 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1684-0) | 2020-08-14 | No | No | Historical |
| 71335-1684-1 | 71335168401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1684-1) | 2020-08-07 | No | No | Historical |
| 71335-1684-2 | 71335168402 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1684-2) | 2020-07-31 | No | No | Historical |
| 71335-1684-3 | 71335168403 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1684-3) | 2020-09-30 | No | No | Historical |
| 71335-1684-4 | 71335168404 | 56 TABLET, FILM COATED in 1 BOTTLE (71335-1684-4) | 2024-05-20 | No | No | Historical |
| 71335-1684-5 | 71335168405 | 84 TABLET, FILM COATED in 1 BOTTLE (71335-1684-5) | 2022-04-29 | No | No | Historical |
| 71335-1684-6 | 71335168406 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1684-6) | 2020-09-03 | No | No | Historical |
| 71335-1684-7 | 71335168407 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1684-7) | 2021-03-18 | No | No | Historical |
| 71335-1684-8 | 71335168408 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-1684-8) | 2020-09-10 | No | No | Historical |
| 71335-1684-9 | 71335168409 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-1684-9) | 2022-04-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| topiramate | Bryant Ranch Prepack | 2024-05-20 | HUMAN PRESCRIPTION DRUG LABEL | 8 |