TOPIRAMATE
- Product NDC
- 13668-034
- 11-digit product format
- 136680034
- Labeler code
- 13668
- Product ID
- 13668-034_16ea5453-3213-4fef-9918-92f5c7179798
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA079153
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- 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
- 2024-12-31
- 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 |
|---|
| 13668-034-01 | 13668003401 | 100 TABLET in 1 BOTTLE (13668-034-01) | 100 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-034-05 | 13668003405 | 500 TABLET in 1 BOTTLE (13668-034-05) | 500 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-034-15 | 13668003415 | 1500 TABLET in 1 BOTTLE (13668-034-15) | 1500 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-034-60 | 13668003460 | 60 TABLET in 1 BOTTLE (13668-034-60) | 60 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-034-77 | 13668003477 | 80 TABLET in 1 DOSE PACK (13668-034-77) | 80 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |