Topiramate
- Product NDC
- 70518-2899
- 11-digit product format
- 705182899
- Labeler code
- 70518
- Product ID
- 70518-2899_d787ec41-be8a-f5a7-e053-2995a90a885e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077627
- Marketing category
- ANDA
- Marketing start
- 2020-09-30
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 25 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2899 | TOPIRAMATE TABLET, FILM COATED [REMEDYREPACK INC.] | 7 | Legacy NDC | 20250406_edfec590-a303-4763-95a6-dfcc7602325d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2899-0 | 70518289900 | 30 POUCH in 1 BOX (70518-2899-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2899-1) | 30 pouch | 2020-09-30 | 0000-00-00 | No | No | Current |