Topiramate
- Product NDC
- 65862-174
- 11-digit product format
- 658620174
- Labeler code
- 65862
- Product ID
- 65862-174_67afee59-3d84-418f-832c-d00abd43fe5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA078462
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- 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
- 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 | 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 |
|---|
| 65862-174-05 | Topiramate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 33 |
| 65862-174-60 | Topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 33 |
| 65862-174-99 | Topiramate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 33 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-174 | TOPIRAMATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 31 | Current NDC, Legacy NDC, 3 package rows | 20250508_32b48ea0-a215-43b8-83b4-a5435a686d68.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 |
|---|
| 65862-174-05 | 65862017405 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-174-05) | 2022-04-11 | 0000-00-00 | No | No | Current |
| 65862-174-35 | 65862017435 | 3500 TABLET, FILM COATED in 1 BAG (65862-174-35) | 27-MAR-09 | | | | Current |
| 65862-174-60 | 65862017460 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-174-60) | 2009-03-27 | 0000-00-00 | No | No | Current |
| 65862-174-99 | 65862017499 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-174-99) | 2022-04-11 | 0000-00-00 | No | No | Current |