Topiramate
- Product NDC
- 43063-735
- 11-digit product format
- 430630735
- Labeler code
- 43063
- Product ID
- 43063-735_43e5361f-8382-82ab-e063-6294a90a3c5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2014-06-12
- 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 199888 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-735-15 | Topiramate | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | | 26 |
| 43063-735-30 | Topiramate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 26 |
| 43063-735-60 | Topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 26 |
| 43063-735-90 | Topiramate | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-735 | TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 24 | Current NDC, Legacy NDC, 4 package rows | 20250123_1f327383-beb3-4d15-add6-5f1c749f2b3f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-735-15 | 43063073515 | 15 TABLET in 1 BOTTLE, PLASTIC (43063-735-15) | 15 tablet | 2017-10-24 | 0000-00-00 | No | No | Current |
| 43063-735-30 | 43063073530 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-735-30) | 30 tablet | 2017-01-25 | 0000-00-00 | No | No | Current |
| 43063-735-60 | 43063073560 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-735-60) | 60 tablet | 2017-01-05 | 0000-00-00 | No | No | Current |
| 43063-735-90 | 43063073590 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-735-90) | 90 tablet | 2025-11-18 | | No | No | Current |