Topiramate
- Product NDC
- 0832-1075
- 11-digit product format
- 008321075
- Labeler code
- 0832
- Product ID
- 0832-1075_4c23c6e3-1684-b1fd-e063-6394a90a99a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- NDA205122
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-07-07
- Substance
- TOPIRAMATE
- Active strength
- 150 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topiramate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 1494769, 1812419, 1812421, 1812425, 1812427 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0832-1075-15 | Topiramate | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 22 |
| 0832-1075-30 | Topiramate | 1 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 1 | | 22 |
| 0832-1075-30 | Topiramate | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 22 |
| 0832-1075-90 | Topiramate | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 22 |
| 0832-1075-90 | Topiramate | 1 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 1 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-1075 | TOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC] | 20 | Current NDC, Legacy NDC, 5 package rows | 20250429_691d276c-9cc1-4d39-828f-0f44d7ef6328.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 |
|---|
| 0832-1075-15 | 00832107515 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-1075-15) | | 2014-07-07 | 0000-00-00 | No | No | Current |
| 0832-1075-30 | 00832107530 | 1 BOTTLE in 1 CARTON (0832-1075-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2014-07-07 | 0000-00-00 | No | No | Current |
| 0832-1075-90 | 00832107590 | 1 BOTTLE in 1 CARTON (0832-1075-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2014-07-07 | 0000-00-00 | No | No | Current |