topiramate
- Product NDC
- 70518-2322
- 11-digit product format
- 705182322
- Labeler code
- 70518
- Product ID
- 70518-2322_db5f420b-ad91-0b08-e053-2a95a90a8e5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2019-09-23
- 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2322-1 | 70518232201 | 100 POUCH in 1 BOX (70518-2322-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-2322-2) | 100 pouch | 2019-12-13 | 0000-00-00 | No | No | Current |