topiramate
- Product NDC
- 80425-0488
- 11-digit product format
- 804250488
- Labeler code
- 80425
- Product ID
- 80425-0488_2cf7a5af-3e85-68de-e063-6394a90a4aa0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2025-01-30
- 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 |
|---|
| 80425-0488-1 | topiramate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 80425-0488-2 | topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 80425-0488-3 | topiramate | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0488 | TOPIRAMATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 3 package rows | 20250201_2cf7ce9e-afc2-f94e-e063-6394a90a35d0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0488-1 | 80425048801 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0488-1) | 2025-01-30 | No | No | Historical |
| 80425-0488-2 | 80425048802 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0488-2) | 2025-01-30 | No | No | Historical |
| 80425-0488-3 | 80425048803 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0488-3) | 2025-01-30 | No | No | Historical |