TOPIRAMATE
- Product NDC
- 61919-318
- 11-digit product format
- 619190318
- Labeler code
- 61919
- Product ID
- 61919-318_b8ba0422-dd85-cd4f-e053-2995a90ad3f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2021-01-12
- 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
- 2022-12-31
- 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 |
|---|
| 61919-318-30 | TOPIRAMATE | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 61919-318-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
| 61919-318-72 | TOPIRAMATE | 120 in 1 BOTTLE | TABLET | 120 | | 4 |
| 61919-318-90 | TOPIRAMATE | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-318 | TOPIRAMATE TABLET, FILM COATED TOPIRAMATE TABLET [DIRECT_RX] | 4 | Legacy NDC, 4 package rows | 20230316_8a35067c-2f44-52b3-e053-2995a90a6bc1.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 |
|---|
| 61919-318-30 | 61919031830 | 30 TABLET in 1 BOTTLE (61919-318-30) | 30 tablet | 2021-01-12 | 0000-00-00 | No | No | Current |
| 61919-318-60 | 61919031860 | 60 TABLET in 1 BOTTLE (61919-318-60) | 60 tablet | 2021-01-12 | 0000-00-00 | No | No | Current |
| 61919-318-72 | 61919031872 | 120 TABLET in 1 BOTTLE (61919-318-72) | 120 tablet | 2021-01-12 | 0000-00-00 | No | No | Current |
| 61919-318-90 | 61919031890 | 90 TABLET in 1 BOTTLE (61919-318-90) | 90 tablet | 2021-01-12 | 0000-00-00 | No | No | Current |