Topiramate
- Product NDC
- 63629-6871
- 11-digit product format
- 636296871
- Labeler code
- 63629
- Product ID
- 63629-6871_cc1d0a52-17eb-4934-b283-6fac3057e955
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076575
- Marketing category
- ANDA
- Marketing start
- 2009-04-17
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 15 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
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 |
|---|
| 63629-6871-1 | 63629687101 | 30 CAPSULE, COATED PELLETS in 1 BOTTLE (63629-6871-1) | 2015-12-22 | 0000-00-00 | No | No | Current |
| 63629-6871-2 | 63629687102 | 70 CAPSULE, COATED PELLETS in 1 BOTTLE (63629-6871-2) | 2015-12-22 | 0000-00-00 | No | No | Current |