Topiramate
- Product NDC
- 72789-471
- 11-digit product format
- 727890471
- Labeler code
- 72789
- Product ID
- 72789-471_4db56547-93e9-b78e-e063-6294a90abf7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078462
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- 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 | 199888 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-471-90 | Topiramate | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 34 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-471 | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 32 | Current NDC, 1 package rows | 20250316_5424d59e-74f1-4c3c-b737-79e9776e0b60.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-471-90 | 72789047190 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-471-90) | 2025-01-13 | No | No | Current |