topiramate
- Product NDC
- 67046-0375
- 11-digit product format
- 670460375
- Labeler code
- 67046
- Product ID
- 67046-0375_5461ffcb-b69d-ddc6-e063-6294a90a1dd2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2026-06-16
- 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]
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A078235-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | AB | | 2009-03-27 |
| A078235-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | AB | | 2009-03-27 |
| A078235-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | AB | | 2009-03-27 |
| A078235-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | AB | | 2009-03-27 |
Therapeutic equivalence codes#
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- topiramate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 199888 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Status |
|---|
| 67046-0375-3 | 67046037503 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0375-3) | 2026-06-16 | 0 | Current |