topiramate
- Product NDC
- 68788-8835
- 11-digit product format
- 687888835
- Labeler code
- 68788
- Product ID
- 68788-8835_bbf0f882-1dcc-415d-82bb-acc64f4dc2bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2025-02-21
- Substance
- TOPIRAMATE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 199889 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8835-3 | topiramate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 68788-8835-5 | topiramate | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 1 |
| 68788-8835-6 | topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 68788-8835-9 | topiramate | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8835 | TOPIRAMATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 4 package rows | 20250224_bbf0f882-1dcc-415d-82bb-acc64f4dc2bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8835-3 | 68788883503 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8835-3) | 2025-02-21 | No | No | Historical |
| 68788-8835-5 | 68788883505 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8835-5) | 2025-02-21 | No | No | Historical |
| 68788-8835-6 | 68788883506 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8835-6) | 2025-02-21 | No | No | Historical |
| 68788-8835-9 | 68788883509 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8835-9) | 2025-02-21 | No | No | Historical |