Topiramate
- Product NDC
- 61919-212
- 11-digit product format
- 619190212
- Labeler code
- 61919
- Product ID
- 61919-212_e9be945a-7c09-3253-e053-2995a90abab4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2022-08-04
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 200 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
- 2023-12-31
- 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 |
|---|
| 61919-212-60 | 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 |
|---|
| 61919-212 | TOPIRAMATE TABLET [DIRECT_RX] | 1 | Legacy NDC, 1 package rows | 20220929_e9be945a-7c08-3253-e053-2995a90abab4.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 |
|---|
| 61919-212-60 | 61919021260 | 60 TABLET in 1 BOTTLE (61919-212-60) | 60 tablet | 2022-08-04 | 0000-00-00 | No | No | Current |