Topiramate
- Product NDC
- 55700-894
- 11-digit product format
- 557000894
- Labeler code
- 55700
- Product ID
- 55700-894_0e1a7d8c-e87d-4596-8b5b-0d887966f858
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2021-03-05
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-894-30 | 55700089430 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-894-30) | 2021-03-05 | 0000-00-00 | No | No | Current |
| 55700-894-60 | 55700089460 | 60 TABLET, FILM COATED in 1 BOTTLE (55700-894-60) | 2021-03-05 | 0000-00-00 | No | No | Current |
| 55700-894-90 | 55700089490 | 90 TABLET, FILM COATED in 1 BOTTLE (55700-894-90) | 2021-03-05 | 0000-00-00 | No | No | Current |