Topiramate
- Product NDC
- 55700-691
- 11-digit product format
- 557000691
- Labeler code
- 55700
- Product ID
- 55700-691_e1bba9c5-96b7-4db6-89b1-1cf77614db52
- 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
- 2018-10-26
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-691-30 | 55700069130 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-691-30) | 2018-10-26 | 0000-00-00 | No | No | Current |
| 55700-691-60 | 55700069160 | 60 TABLET, FILM COATED in 1 BOTTLE (55700-691-60) | 2018-10-26 | 0000-00-00 | No | No | Current |
| 55700-691-90 | 55700069190 | 90 TABLET, FILM COATED in 1 BOTTLE (55700-691-90) | 2018-10-26 | 0000-00-00 | No | No | Current |