Topiramate
- Product NDC
- 55700-227
- 11-digit product format
- 557000227
- Labeler code
- 55700
- Product ID
- 55700-227_3ac87963-d6a8-4cda-9a59-284ebbec4676
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products LLC
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2014-06-12
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-227-27 | 55700022727 | 270 TABLET in 1 BOTTLE (55700-227-27) | 270 tablet | 2017-11-17 | 0000-00-00 | No | No | Current |
| 55700-227-30 | 55700022730 | 30 TABLET in 1 BOTTLE (55700-227-30) | 30 tablet | 2021-12-07 | 0000-00-00 | No | No | Current |
| 55700-227-60 | 55700022760 | 60 TABLET in 1 BOTTLE (55700-227-60) | 60 tablet | 2017-11-17 | 0000-00-00 | No | No | Current |
| 55700-227-90 | 55700022790 | 90 TABLET in 1 BOTTLE (55700-227-90) | 90 tablet | 2017-11-17 | 0000-00-00 | No | No | Current |