topiramate
- Product NDC
- 71205-202
- 11-digit product format
- 712050202
- Labeler code
- 71205
- Product ID
- 71205-202_ebe4977e-5a33-4587-8a06-f46c4d5b92bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- 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
- 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 | 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 |
|---|
| 71205-202-30 | topiramate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 71205-202-60 | topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 2 |
| 71205-202-90 | topiramate | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-202 | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 3 package rows | 20191012_2d6d236b-9808-4e18-b521-e7435d1fd5cc.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 |
|---|
| 71205-202-30 | 71205020230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-202-30) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 71205-202-60 | 71205020260 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-202-60) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 71205-202-90 | 71205020290 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-202-90) | 2019-01-01 | 0000-00-00 | No | No | Current |