Topiramate
- Product NDC
- 43353-696
- 11-digit product format
- 433530696
- Labeler code
- 43353
- Product ID
- 43353-696_1166a6cd-e221-43fb-825f-9f1489ec967b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2011-07-08
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-696 | TOPIRAMATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC | 20171127_23d9e299-f9a3-4c91-91e0-0aaeeb6c3772.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-696-60 | 43353069660 | 90 TABLET in 1 BOTTLE (43353-696-60) | 90 tablet | 2011-07-12 | 0000-00-00 | No | No | Current |
| 43353-696-80 | 43353069680 | 180 TABLET in 1 BOTTLE (43353-696-80) | 180 tablet | 2011-08-10 | 0000-00-00 | No | No | Current |