Topiramate
- Product NDC
- 50436-9951
- 11-digit product format
- 504369951
- Labeler code
- 50436
- Product ID
- 50436-9951_2d429965-b6d0-4e9e-9c7c-3d240f2baf8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- 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
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 50436-9951-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3b76-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 1996 |
| 50436-9951-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3b76-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 1996 |
| 50436-9951-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3b76-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP 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 |
|---|
| 50436-9951-1 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | | 7 |
| 50436-9951-2 | Topiramate | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 50436-9951-3 | Topiramate | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-9951 | TOPIRAMATE TABLET [UNIT DOSE SERVICES] | 7 | Legacy NDC, 3 package rows | 20190531_af3eb64f-edfb-470f-924b-ef592b5b88dc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 50436-9951-1 | 50436995101 | 60 in 1 BOTTLE | Historical |
| 50436-9951-2 | 50436995102 | 30 in 1 BOTTLE | Historical |
| 50436-9951-3 | 50436995103 | 90 in 1 BOTTLE | Historical |