Topiramate
- Product NDC
- 43063-729
- 11-digit product format
- 430630729
- Labeler code
- 43063
- Product ID
- 43063-729_39f936c5-d108-6804-e063-6394a90add94
- 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
- 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
- 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 199889 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-729-07 | Topiramate | 7 in 1 BOTTLE, PLASTIC | TABLET | 7 | | 22 |
| 43063-729-21 | Topiramate | 21 in 1 BOTTLE, PLASTIC | TABLET | 21 | | 22 |
| 43063-729-28 | Topiramate | 28 in 1 BOTTLE, PLASTIC | TABLET | 28 | | 22 |
| 43063-729-30 | Topiramate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 22 |
| 43063-729-60 | Topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-729 | TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] | 21 | Current NDC, Legacy NDC, 5 package rows | 20250123_9e516204-8f39-43c9-9f7e-d9777586f321.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 |
|---|
| 43063-729-07 | 43063072907 | 7 TABLET in 1 BOTTLE, PLASTIC (43063-729-07) | 7 tablet | 2018-03-07 | 0000-00-00 | No | No | Current |
| 43063-729-21 | 43063072921 | 21 TABLET in 1 BOTTLE, PLASTIC (43063-729-21) | 21 tablet | 2017-01-31 | 0000-00-00 | No | No | Current |
| 43063-729-28 | 43063072928 | 28 TABLET in 1 BOTTLE, PLASTIC (43063-729-28) | 28 tablet | 2016-12-28 | 0000-00-00 | No | No | Current |
| 43063-729-30 | 43063072930 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-729-30) | 30 tablet | 2017-12-31 | 0000-00-00 | No | No | Current |
| 43063-729-60 | 43063072960 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-729-60) | 60 tablet | 2016-11-29 | 0000-00-00 | No | No | Current |