Topiramate
- Product NDC
- 43353-695
- 11-digit product format
- 433530695
- Labeler code
- 43353
- Product ID
- 43353-695_20fe0892-ca2f-4934-83c2-c88c9d48189a
- 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
- 25 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 |
|---|
| 43353-695 | TOPIRAMATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC | 20171127_2524b6fd-ada8-4f08-a28a-59de7e8d6f92.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-695-60 | 43353069560 | 90 TABLET in 1 BOTTLE (43353-695-60) | 90 tablet | 2011-07-20 | 0000-00-00 | No | No | Current |
| 43353-695-80 | 43353069580 | 180 TABLET in 1 BOTTLE (43353-695-80) | 180 tablet | 2011-07-12 | 0000-00-00 | No | No | Current |