Topiramate
- Product NDC
- 80425-0195
- 11-digit product format
- 804250195
- Labeler code
- 80425
- Product ID
- 80425-0195_2a9a0577-70c7-0284-e063-6394a90ae582
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2022-06-14
- Substance
- TOPIRAMATE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 151226 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0195-2 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 80425-0195-3 | Topiramate | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0195 | TOPIRAMATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250101_d8dff98f-185e-77ba-e053-2995a90aed2f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0195-2 | 80425019502 | 60 TABLET in 1 BOTTLE (80425-0195-2) | 60 tablet | 2024-02-25 | No | No | Historical |
| 80425-0195-3 | 80425019503 | 90 TABLET in 1 BOTTLE (80425-0195-3) | 90 tablet | 2024-02-25 | No | No | Historical |