Topiramate
- Product NDC
- 43063-573
- 11-digit product format
- 430630573
- Labeler code
- 43063
- Product ID
- 43063-573_db7491c0-3b7d-64e9-e053-2995a90aab98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077627
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-573-15 | 43063057315 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-573-15) | 2015-11-24 | 0000-00-00 | No | No | Current |
| 43063-573-30 | 43063057330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-573-30) | 2015-11-24 | 0000-00-00 | No | No | Current |
| 43063-573-60 | 43063057360 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-573-60) | 2015-11-24 | 0000-00-00 | No | No | Current |