topiramate
- Product NDC
- 50090-3926
- 11-digit product format
- 500903926
- Labeler code
- 50090
- Product ID
- 50090-3926_fe5a34c2-c3c9-42a4-89a1-9e4905fd81bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- 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
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3926 | TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 14 | Legacy NDC | 20231213_88156c4e-bc29-497d-8110-e59d800ff38a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-3926-0 | 50090392600 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-3926-0) | 2018-12-07 | 0000-00-00 | No | No | Current |
| 50090-3926-1 | 50090392601 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-3926-1) | 2018-12-07 | 0000-00-00 | No | No | Current |
| 50090-3926-2 | 50090392602 | 120 TABLET, FILM COATED in 1 BOTTLE (50090-3926-2) | 2018-12-07 | 0000-00-00 | No | No | Current |
| 50090-3926-3 | 50090392603 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-3926-3) | 2022-03-10 | 0000-00-00 | No | No | Current |