topiramate
- Product NDC
- 80425-0398
- 11-digit product format
- 804250398
- Labeler code
- 80425
- Product ID
- 80425-0398_1a16d6f8-c5e9-d850-e063-6294a90a08cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2024-06-04
- Substance
- TOPIRAMATE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 199889 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0398-1 | topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 80425-0398-2 | topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 80425-0398-3 | topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0398 | TOPIRAMATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 3 package rows | 20240606_1a16d6a9-3dd1-ede8-e063-6294a90afe75.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0398-1 | 80425039801 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0398-1) | 2024-06-04 | No | No | Historical |
| 80425-0398-2 | 80425039802 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0398-2) | 2024-06-04 | No | No | Historical |
| 80425-0398-3 | 80425039803 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0398-3) | 2024-06-04 | No | No | Historical |