topiramate
- Product NDC
- 50090-2248
- 11-digit product format
- 500902248
- Labeler code
- 50090
- Product ID
- 50090-2248_36a35600-dfcb-47be-aa06-22ba531f0921
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-2248-0 | topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 25 |
| 50090-2248-1 | topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 25 |
| 50090-2248-2 | topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-2248 | TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 22 | Legacy NDC, 3 package rows | 20241010_a5cffe7a-fdee-487a-bafb-a2d43e76c23c.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 |
|---|
| 50090-2248-0 | 50090224800 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-2248-0) | 2015-12-03 | 0000-00-00 | No | No | Current |
| 50090-2248-1 | 50090224801 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-2248-1) | 2015-12-03 | 0000-00-00 | No | No | Current |
| 50090-2248-2 | 50090224802 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-2248-2) | 2015-12-03 | 0000-00-00 | No | No | Current |