topiramate
- Product NDC
- 50090-5853
- 11-digit product format
- 500905853
- Labeler code
- 50090
- Product ID
- 50090-5853_4ed19ca8-e239-41ce-afc3-4211caa41781
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-5853-0 | 2023-02-07 | C162847 | 48780-1 | f386c64a-370e-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996 |
| 50090-5853-1 | 2023-02-07 | C162847 | 48780-1 | f386c64a-370e-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996 |
| 50090-5853-2 | 2023-02-07 | C162847 | 48780-1 | f386c64a-370e-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996 |
| 50090-5853-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-370e-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996 |
| 50090-5853-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-370e-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996 |
| 50090-5853-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-370e-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5853-0 | topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 50090-5853-1 | topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
| 50090-5853-2 | topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5853 | TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 5 | Current NDC, Legacy NDC, 3 package rows | 20231125_f7f2d1bc-9c65-4798-826f-6902b3ec81dc.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 |
|---|
| 50090-5853-0 | 50090585300 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-5853-0) | 2021-11-10 | 0000-00-00 | No | No | Current |
| 50090-5853-1 | 50090585301 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5853-1) | 2021-11-10 | 0000-00-00 | No | No | Current |
| 50090-5853-2 | 50090585302 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5853-2) | 2021-11-10 | 0000-00-00 | No | No | Current |