Topiramate
- Product NDC
- 55700-226
- 11-digit product format
- 557000226
- Labeler code
- 55700
- Product ID
- 55700-226_9872fa01-7e62-4240-b11f-b18fdffb800f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2014-06-12
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 200 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 |
|---|
| 55700-226-30 | 55700022630 | 30 TABLET in 1 BOTTLE (55700-226-30) | 30 tablet | 2018-06-15 | 0000-00-00 | No | No | Current |
| 55700-226-60 | 55700022660 | 60 TABLET in 1 BOTTLE (55700-226-60) | 60 tablet | 2015-07-24 | 0000-00-00 | No | No | Current |