topiramate
- Product NDC
- 55154-7146
- 11-digit product format
- 551547146
- Labeler code
- 55154
- Product ID
- 55154-7146_7febe648-24e1-4baa-9718-2473f29a5784
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2012-06-01
- Substance
- TOPIRAMATE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 199888, 199889 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-7146-0 | topiramate | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 11 |
| 55154-7146-0 | topiramate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-7146 | TOPIRAMATE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241116_e5bc696e-040d-4d3e-b38c-9548a38fa936.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 |
|---|
| 55154-7146-0 | 55154714600 | 10 BLISTER PACK in 1 BAG (55154-7146-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-06-01 | 0000-00-00 | No | No | Current |