Topiramate
- Product NDC
- 53217-274
- 11-digit product format
- 532170274
- Labeler code
- 53217
- Product ID
- 53217-274_48b93744-8bad-46fc-aff5-39197b5ff2bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2016-07-22
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53217-274-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2959-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use [topiramate tablets, USP] safely and effectively. See full prescribing information for[topiramate tablets, USP] Initial U.S. Approval:[1996] |
| 53217-274-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2959-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use [topiramate tablets, USP] safely and effectively. See full prescribing information for[topiramate tablets, USP] Initial U.S. Approval:[1996] |
| 53217-274-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2959-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use [topiramate tablets, USP] safely and effectively. See full prescribing information for[topiramate tablets, USP] Initial U.S. Approval:[1996] |
| 53217-274-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2959-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use [topiramate tablets, USP] safely and effectively. See full prescribing information for[topiramate tablets, USP] Initial U.S. Approval:[1996] |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-274-02 | Topiramate | 120 in 1 BOTTLE | TABLET | 120 | | 1 |
| 53217-274-30 | Topiramate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53217-274-60 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 53217-274-90 | Topiramate | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-274 | TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 4 package rows | 20170420_37da3ab9-df44-444e-b506-41204601cf43.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-274-02 | 53217027402 | 120 in 1 BOTTLE | Historical |
| 53217-274-30 | 53217027430 | 30 in 1 BOTTLE | Historical |
| 53217-274-60 | 53217027460 | 60 in 1 BOTTLE | Historical |
| 53217-274-90 | 53217027490 | 90 in 1 BOTTLE | Historical |