topiramate
- Product NDC
- 65841-650
- 11-digit product format
- 658410650
- Labeler code
- 65841
- Product ID
- 65841-650_85c62092-3b8c-43af-a980-e2d959e0c341
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA078235
- 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
- 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 |
|---|
| 65841-650-01 | topiramate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 65841-650-05 | topiramate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
| 65841-650-14 | topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
| 65841-650-16 | topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-650 | TOPIRAMATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240817_57016639-89fe-43ad-89c4-5e7a756dddec.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 |
|---|
| 65841-650-01 | 65841065001 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-650-01) | 2009-03-27 | 0000-00-00 | No | No | Current |
| 65841-650-05 | 65841065005 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-650-05) | 2009-03-27 | 0000-00-00 | No | No | Current |
| 65841-650-14 | 65841065014 | 60 TABLET, FILM COATED in 1 BOTTLE (65841-650-14) | 2009-03-27 | 0000-00-00 | No | No | Current |
| 65841-650-16 | 65841065016 | 90 TABLET, FILM COATED in 1 BOTTLE (65841-650-16) | 2009-03-27 | 0000-00-00 | No | No | Current |