TOPIRAMATE
- Product NDC
- 72865-313
- 11-digit product format
- 728650313
- Labeler code
- 72865
- Product ID
- 72865-313_297988b4-69fb-4691-92e0-ee5da80b0125
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals, Inc.
- Application
- ANDA215414
- Marketing category
- ANDA
- Marketing start
- 2025-07-10
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TOPIRAMATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 151226, 199888, 199889, 199890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72865-313-10 | TOPIRAMATE | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
| 72865-313-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72865-313-10 | 72865031310 | 1000 TABLET in 1 BOTTLE (72865-313-10) | 1000 tablet | 2025-07-10 | No | No | Current |
| 72865-313-60 | 72865031360 | 60 TABLET in 1 BOTTLE (72865-313-60) | 60 tablet | 2025-07-10 | No | No | Current |