Topiramate
- Product NDC
- 71205-819
- 11-digit product format
- 712050819
- Labeler code
- 71205
- Product ID
- 71205-819_8bd03bb2-3b9b-4707-a9a4-5618ddc3832f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topiramate
- Listing expiration
- 2026-12-31
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 |
|---|
| 71205-819-30 | Topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 71205-819-60 | Topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 71205-819-90 | Topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-819 | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 3 package rows | 20230708_8bd03bb2-3b9b-4707-a9a4-5618ddc3832f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-819-30 | 71205081930 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-819-30) | 2023-07-03 | No | No | Current |
| 71205-819-60 | 71205081960 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-819-60) | 2023-07-03 | No | No | Current |
| 71205-819-90 | 71205081990 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-819-90) | 2023-07-03 | No | No | Current |