topiramate
- Product NDC
- 71335-1064
- 11-digit product format
- 713351064
- Labeler code
- 71335
- Product ID
- 71335-1064_32edb528-3bc4-b4e0-e063-6294a90afd5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- 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 |
|---|
| 71335-1064-0 | topiramate | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 5 |
| 71335-1064-1 | topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 71335-1064-2 | topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 71335-1064-3 | topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
| 71335-1064-4 | topiramate | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 5 |
| 71335-1064-5 | topiramate | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 5 |
| 71335-1064-6 | topiramate | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 5 |
| 71335-1064-7 | topiramate | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 5 |
| 71335-1064-8 | topiramate | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 5 |
| 71335-1064-9 | topiramate | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1064 | TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 10 package rows | 20250418_073d075d-d019-4834-b55d-9b9587914975.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 |
|---|
| 71335-1064-0 | 71335106400 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1064-0) | 2019-01-23 | 0000-00-00 | No | No | Current |
| 71335-1064-1 | 71335106401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1064-1) | 2019-01-23 | 0000-00-00 | No | No | Current |
| 71335-1064-2 | 71335106402 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1064-2) | 2019-01-11 | 0000-00-00 | No | No | Current |
| 71335-1064-3 | 71335106403 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1064-3) | 2019-01-15 | 0000-00-00 | No | No | Current |
| 71335-1064-4 | 71335106404 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1064-4) | 2019-01-23 | 0000-00-00 | No | No | Current |
| 71335-1064-5 | 71335106405 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1064-5) | 2019-01-31 | 0000-00-00 | No | No | Current |
| 71335-1064-6 | 71335106406 | 80 TABLET, FILM COATED in 1 BOTTLE (71335-1064-6) | 2019-01-23 | 0000-00-00 | No | No | Current |
| 71335-1064-7 | 71335106407 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-1064-7) | 2019-05-31 | 0000-00-00 | No | No | Current |
| 71335-1064-8 | 71335106408 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-1064-8) | 2019-01-23 | 0000-00-00 | No | No | Current |
| 71335-1064-9 | 71335106409 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1064-9) | 2019-01-23 | 0000-00-00 | No | No | Current |