TOPIRAMATE
- Product NDC
- 23155-894
- 11-digit product format
- 231550894
- Labeler code
- 23155
- Product ID
- 23155-894_c6498e0a-7dbe-4132-897b-a2721fb2190c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate spinkle
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA078418
- Marketing category
- ANDA
- Marketing start
- 2024-02-16
- Marketing end
- 2026-08-31
- Substance
- TOPIRAMATE
- Active strength
- 15 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TOPIRAMATE
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 15 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 |
|---|
| 23155-894-06 | TOPIRAMATE | 60 in 1 BOTTLE | CAPSULE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-894 | TOPIRAMATE (TOPIRAMATE SPINKLE) CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20250325_1730870d-e661-41f9-bd0d-d8daaf087819.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 23155-894-06 | 23155089406 | 60 CAPSULE in 1 BOTTLE (23155-894-06) | 60 capsule | 2024-02-16 | 2026-08-31 | No | No | Historical |