Topiramate
- Product NDC
- 45865-459
- 11-digit product format
- 458650459
- Labeler code
- 45865
- Product ID
- 45865-459_71c6e31c-13dd-7f9c-e053-2a95a90ae742
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2014-06-12
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 50 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-459-30 | Topiramate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 45865-459-60 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-459 | TOPIRAMATE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 2 package rows | 20180725_71c6e31c-13dc-7f9c-e053-2a95a90ae742.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 |
|---|
| 45865-459-30 | 45865045930 | 30 TABLET in 1 BOTTLE (45865-459-30) | 30 tablet | 2018-01-01 | 0000-00-00 | No | No | Current |
| 45865-459-60 | 45865045960 | 60 TABLET in 1 BOTTLE (45865-459-60) | 60 tablet | 2018-01-01 | 0000-00-00 | No | No | Current |