Topiramate
- Product NDC
- 51407-894
- 11-digit product format
- 514070894
- Labeler code
- 51407
- Product ID
- 51407-894_2f8ccf6c-5e9f-383e-e063-6394a90ad933
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA217694
- Marketing category
- ANDA
- Marketing start
- 2023-12-05
- Substance
- TOPIRAMATE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 205315, 205316 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51407-894-60 | Topiramate | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51407-894 | TOPIRAMATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] | 3 | Current NDC, 1 package rows | 20250411_163e9f2d-27be-6d3f-e063-6394a90a5884.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51407-894-60 | 51407089460 | 60 CAPSULE in 1 BOTTLE, PLASTIC (51407-894-60) | 60 capsule | 2024-03-19 | No | No | Current |