topiramate
- Product NDC
- 70518-2498
- 11-digit product format
- 705182498
- Labeler code
- 70518
- Product ID
- 70518-2498_dc018365-e7b9-04ee-e053-2995a90a57a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2019-12-18
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2498-0 | 70518249800 | 100 POUCH in 1 BOX (70518-2498-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2498-1) | 100 pouch | 2019-12-18 | 0000-00-00 | No | No | Current |
| 70518-2498-2 | 70518249802 | 30 POUCH in 1 BOX (70518-2498-2) > 1 TABLET, FILM COATED in 1 POUCH (70518-2498-3) | 30 pouch | 2020-09-14 | 0000-00-00 | No | No | Current |