Topiramate
- Product NDC
- 68071-3012
- 11-digit product format
- 680713012
- Labeler code
- 68071
- Product ID
- 68071-3012_b9e6ec75-9730-7e6e-e053-2a95a90a3f66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 25 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
- 2022-12-31
- 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 |
|---|
| 68071-3012-3 | 68071301203 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3012-3) | 2017-03-10 | 0000-00-00 | No | No | Current |
| 68071-3012-6 | 68071301206 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3012-6) | 2017-03-10 | 0000-00-00 | No | No | Current |
| 68071-3012-9 | 68071301209 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3012-9) | 2017-03-10 | 0000-00-00 | No | No | Current |