Topiramate
- Product NDC
- 68382-358
- 11-digit product format
- 683820358
- Labeler code
- 68382
- Product ID
- 68382-358_2535bcc8-fac7-4b15-8c6f-fd6675655fd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA207382
- Marketing category
- ANDA
- Marketing start
- 2023-11-13
- 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
- 2027-12-31
- 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 |
|---|
| 68382-358-01 | 68382035801 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-01) | | 2023-11-13 | No | No | Historical |
| 68382-358-05 | 68382035805 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-05) | | 2023-11-13 | No | No | Historical |
| 68382-358-06 | 68382035806 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-06) | | 2023-11-13 | No | No | Historical |
| 68382-358-78 | 68382035878 | 3 BLISTER PACK in 1 CARTON (68382-358-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-358-30) | 3 blister pack | 2023-11-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Topiramate | Zydus Pharmaceuticals USA Inc. | Zydus Worldwide DMCC | Zydus Lifesciences Limited | 2026-03-30 | HUMAN PRESCRIPTION DRUG LABEL | 10 |