Topiramate
- Product NDC
- 68462-219
- 11-digit product format
- 684620219
- Labeler code
- 68462
- Product ID
- 68462-219_e4d3b13a-e354-421d-917a-613ad0a3ab35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA217869
- Marketing category
- ANDA
- Marketing start
- 2024-07-16
- Substance
- TOPIRAMATE
- Active strength
- 25 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topiramate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 205315, 205316 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-219-60 | Topiramate | 60 in 1 BOTTLE | CAPSULE, COATED PELLETS | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-219 | TOPIRAMATE CAPSULE, COATED PELLETS [GLENMARK PHARMACEUTICALS INC., USA] | 5 | Current NDC, 1 package rows | 20250524_872927eb-0b61-44bb-9892-3c700b6f2181.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68462-219-60 | 68462021960 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (68462-219-60) | 2024-07-16 | No | No | Current |