topiramate
- Product NDC
- 60760-577
- 11-digit product format
- 607600577
- Labeler code
- 60760
- Product ID
- 60760-577_4bd575ae-1a71-7ab9-e063-6394a90a7185
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2019-09-11
- Substance
- TOPIRAMATE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 151226 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60760-577-60 | topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 6 |
| 60760-577-90 | topiramate | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60760-577 | TOPIRAMATE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250523_92637f92-9d7c-c246-e053-2995a90a0347.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60760-577-60 | 60760057760 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-577-60) | 2025-05-13 | 0000-00-00 | No | No | Current |
| 60760-577-90 | 60760057790 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-577-90) | 2020-01-10 | 0000-00-00 | No | No | Current |