TOPIRAMATE
- Product NDC
- 61919-691
- 11-digit product format
- 619190691
- Labeler code
- 61919
- Product ID
- 61919-691_00ccf645-ff1d-45d0-83a5-69c69dc25456
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DirectRX
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2015-01-01
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 61919-691-30 | TOPIRAMATE | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 61919-691-60 | 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 |
|---|
| 61919-691 | TOPIRAMATE TABLET [DIRECTRX] | 1 | Legacy NDC, 2 package rows | 20151022_45f0fa04-6c5b-4097-a63a-bc9d08f1b743.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 61919-691-30 | 61919069130 | 30 in 1 BOTTLE | Historical |
| 61919-691-60 | 61919069160 | 60 in 1 BOTTLE | Historical |