Topiramate
- Product NDC
- 0615-8139
- 11-digit product format
- 006158139
- Labeler code
- 0615
- Product ID
- 0615-8139_8346efad-e6ee-4384-b042-95683f943e8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA077627
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 2026-06-30
- Substance
- TOPIRAMATE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 151226, 199888, 199889 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8139-39 | Topiramate | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8139 | TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 8 | Current NDC, Legacy NDC, 1 package rows | 20221220_b0036d28-ca99-42c6-81ad-3c93f4a844a1.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 |
|---|
| 0615-8139-39 | 00615813939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8139-39) | 2018-12-07 | 2026-06-30 | No | No | Current |