Topiramate
- Product NDC
- 43063-998
- 11-digit product format
- 430630998
- Labeler code
- 43063
- Product ID
- 43063-998_3a22cbea-53cc-4e02-e063-6294a90aef45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topiramate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-998-30 | Topiramate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 21 |
| 43063-998-60 | Topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-998 | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20240711_021005ab-6a00-40d8-9aee-20c91613b4d5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-998-30 | 43063099830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-998-30) | 2019-08-08 | 0000-00-00 | No | No | Current |
| 43063-998-60 | 43063099860 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-998-60) | 2019-07-30 | 0000-00-00 | No | No | Current |