TOPIRAMATE
- Product NDC
- 61919-172
- 11-digit product format
- 619190172
- Labeler code
- 61919
- Product ID
- 61919-172_9cad60e1-340f-1b7e-e053-2995a90a2a2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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
- 2021-12-31
- 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 |
|---|
| 61919-172-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 61919-172-72 | TOPIRAMATE | 72 in 1 BOTTLE | TABLET | 72 | | 6 |
| 61919-172-90 | TOPIRAMATE | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-172 | TOPIRAMATE TABLET [DIRECT RX] | 6 | Legacy NDC, 3 package rows | 20200122_4ce9b4dd-bcff-4157-a859-aa816e2b1226.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 |
|---|
| 61919-172-60 | 61919017260 | 60 TABLET in 1 BOTTLE (61919-172-60) | 60 tablet | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-172-72 | 61919017272 | 72 TABLET in 1 BOTTLE (61919-172-72) | 72 tablet | 2015-01-01 | 0000-00-00 | No | No | Current |
| 61919-172-90 | 61919017290 | 90 TABLET in 1 BOTTLE (61919-172-90) | 90 tablet | 2014-01-01 | 0000-00-00 | No | No | Current |