Topiramate
- Product NDC
- 68387-559
- 11-digit product format
- 683870559
- Labeler code
- 68387
- Product ID
- 68387-559_f66fe0dd-f036-43c8-8527-c1384dbd6791
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Keltman Pharmaceuticals Inc.
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2010-07-30
- 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 |
|---|
| 68387-559-30 | Topiramate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 68387-559-60 | Topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
| 68387-559-90 | Topiramate | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68387-559 | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | Legacy NDC, 3 package rows | 20110223_47fd4c44-56fa-4864-af5d-7b65c7b746d7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68387-559-30 | 68387055930 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 68387-559-60 | 68387055960 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 68387-559-90 | 68387055990 | 90 in 1 BOTTLE, PLASTIC | Historical |