TOPIRAMATE
- Product NDC
- 68462-370
- 11-digit product format
- 684620370
- Labeler code
- 68462
- Product ID
- 68462-370_4a2276a1-54f6-4de6-8710-c2c088a23e76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA210278
- Marketing category
- ANDA
- Marketing start
- 2021-02-01
- Substance
- TOPIRAMATE
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 1494769, 1812419, 1812421, 1812425, 1812427 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-370-05 | TOPIRAMATE | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 10 |
| 68462-370-30 | TOPIRAMATE | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 10 |
| 68462-370-90 | TOPIRAMATE | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-370 | TOPIRAMATE CAPSULE, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 8 | Current NDC, Legacy NDC, 3 package rows | 20250524_54bfabce-1f8a-40ee-8b55-efce8fe6fbf1.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 |
|---|
| 68462-370-05 | 68462037005 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-05) | 2021-02-01 | 0000-00-00 | No | No | Current |
| 68462-370-30 | 68462037030 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-30) | 2021-02-01 | 0000-00-00 | No | No | Current |
| 68462-370-90 | 68462037090 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-370-90) | 2021-02-01 | 0000-00-00 | No | No | Current |