Topiramate
- Product NDC
- 50090-6827
- 11-digit product format
- 500906827
- Labeler code
- 50090
- Product ID
- 50090-6827_c3f23dde-65de-4566-b22a-0d09f0023f20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2014-06-12
- 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
- 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 199888 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6827-0 | Topiramate | 90 in 1 BOTTLE | TABLET | 90 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6827 | TOPIRAMATE TABLET [A-S MEDICATION SOLUTIONS] | 19 | Current NDC, 1 package rows | 20231128_55e71f43-1cd5-4efc-9641-fda0a09c30f0.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 |
|---|
| 50090-6827-0 | 50090682700 | 90 TABLET in 1 BOTTLE (50090-6827-0) | 90 tablet | 2023-11-21 | No | No | Historical |