Topamax
- Product NDC
- 55289-433
- 11-digit product format
- 552890433
- Labeler code
- 55289
- Product ID
- 55289-433_d9f5fa7c-4ccd-0be8-e053-2a95a90ab074
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- NDA020505
- Marketing category
- NDA
- Marketing start
- 1997-01-01
- 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 |
|---|
| 55289-433-30 | 55289043330 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-433-30) | 2012-01-18 | 0000-00-00 | No | No | Current |