Topiramate
- Product NDC
- 76420-276
- 11-digit product format
- 764200276
- Labeler code
- 76420
- Product ID
- 76420-276_e838b0d0-6869-8c20-e053-2a95a90a4d11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2014-06-12
- 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, 199888, 199889, 199890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-276-30 | Topiramate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 76420-276-60 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 76420-276-90 | Topiramate | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-276 | TOPIRAMATE TABLET [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 3 package rows | 20220911_4e476c33-3590-4c6f-981d-915623cdacf0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-276-30 | 76420027630 | 30 TABLET in 1 BOTTLE (76420-276-30) | 30 tablet | 2022-09-09 | 0000-00-00 | No | No | Current |
| 76420-276-60 | 76420027660 | 60 TABLET in 1 BOTTLE (76420-276-60) | 60 tablet | 2022-09-09 | 0000-00-00 | No | No | Current |
| 76420-276-90 | 76420027690 | 90 TABLET in 1 BOTTLE (76420-276-90) | 90 tablet | 2022-09-09 | 0000-00-00 | No | No | Current |