Topiramate
- Product NDC
- 69097-125
- 11-digit product format
- 690970125
- Labeler code
- 69097
- Product ID
- 69097-125_71f493d9-3aaa-4b13-8057-012e96e11dbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2014-06-12
- Substance
- TOPIRAMATE
- Active strength
- 200 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 | 200 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 |
|---|
| 69097-125-03 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | | 21 |
| 69097-125-12 | Topiramate | 500 in 1 BOTTLE | TABLET | 500 | | 21 |
| 69097-125-15 | Topiramate | 1000 in 1 BOTTLE | TABLET | 1000 | | 21 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-125 | TOPIRAMATE TABLET [CIPLA USA INC.] | 19 | Current NDC, Legacy NDC, 3 package rows | 20230608_ca4ec248-285d-4066-8f89-5ed0c538c4c9.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 |
|---|
| 69097-125-03 | 69097012503 | 60 TABLET in 1 BOTTLE (69097-125-03) | 60 tablet | 2014-06-12 | 0000-00-00 | No | No | Current |
| 69097-125-12 | 69097012512 | 500 TABLET in 1 BOTTLE (69097-125-12) | 500 tablet | 2014-06-12 | 0000-00-00 | No | No | Current |
| 69097-125-15 | 69097012515 | 1000 TABLET in 1 BOTTLE (69097-125-15) | 1000 tablet | 2014-06-12 | 0000-00-00 | No | No | Current |