Topiramate
- Product NDC
- 42291-958
- 11-digit product format
- 422910958
- Labeler code
- 42291
- Product ID
- 42291-958_48c104bb-d8d9-2940-e063-6394a90aeab3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA206210
- Marketing category
- ANDA
- Marketing start
- 2024-10-30
- 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 | 1436239, 1437278, 1437283, 1437288 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-958-30 | Topiramate | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-958 | TOPIRAMATE CAPSULE, EXTENDED RELEASE [AVKARE] | 1 | Current NDC, 1 package rows | 20241101_25b377f7-ea89-fb56-e063-6394a90a239d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-958-30 | 42291095830 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-958-30) | 2024-10-30 | No | No | Current |