TOPIRAMATE
- Product NDC
- 61919-439
- 11-digit product format
- 619190439
- Labeler code
- 61919
- Product ID
- 61919-439_f2140c0c-7b2f-2096-e053-2995a90ad56e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2019-08-19
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 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
- 2024-12-31
- 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 |
|---|
| 61919-439-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 61919-439-72 | TOPIRAMATE | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 3 |
| 61919-439-90 | TOPIRAMATE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
| 61919-439-30 | TOPIRAMATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-439 | TOPIRAMATE TABLET, FILM COATED [DIRECT_RX] | 3 | Legacy NDC, 3 package rows | 20230113_907c4230-257e-45fd-e053-2995a90a9a66.zip |
| 61919-439 | TOPIRAMATE TABLET, FILM COATED [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20230113_907a9929-4e0f-2f14-e053-2a95a90a244f.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 |
|---|
| 61919-439-30 | 61919043930 | 30 TABLET, FILM COATED in 1 BOTTLE (61919-439-30) | 2019-08-19 | 0000-00-00 | No | No | Current |
| 61919-439-60 | 61919043960 | 60 TABLET, FILM COATED in 1 BOTTLE (61919-439-60) | 2019-08-19 | 0000-00-00 | No | No | Current |
| 61919-439-72 | 61919043972 | 120 TABLET, FILM COATED in 1 BOTTLE (61919-439-72) | 2019-08-19 | 0000-00-00 | No | No | Current |
| 61919-439-90 | 61919043990 | 90 TABLET, FILM COATED in 1 BOTTLE (61919-439-90) | 2019-08-19 | 0000-00-00 | No | No | Current |