topiramate
- Product NDC
- 68788-7468
- 11-digit product format
- 687887468
- Labeler code
- 68788
- Product ID
- 68788-7468_0174a6bd-1a4a-44b0-a9d3-d45c6ad9514d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2020-03-02
- 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 |
|---|
| 68788-7468-3 | topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 68788-7468-5 | topiramate | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 6 |
| 68788-7468-6 | topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 68788-7468-9 | topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7468 | TOPIRAMATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240822_be42ed09-350c-4e8a-aff4-6afb242dd599.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7468-3 | 68788746803 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7468-3) | 2020-03-02 | 0000-00-00 | No | No | Current |
| 68788-7468-5 | 68788746805 | 15 TABLET, FILM COATED in 1 BOTTLE (68788-7468-5) | 2020-03-02 | 0000-00-00 | No | No | Current |
| 68788-7468-6 | 68788746806 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7468-6) | 2020-03-02 | 0000-00-00 | No | No | Current |
| 68788-7468-9 | 68788746809 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7468-9) | 2020-03-02 | 0000-00-00 | No | No | Current |