topiramate
- Product NDC
- 51655-746
- 11-digit product format
- 516550746
- Labeler code
- 51655
- Product ID
- 51655-746_4c2ac9fc-c39f-b499-e063-6294a90aed50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2022-12-30
- 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 |
|---|
| 51655-746-26 | topiramate | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
| 51655-746-52 | topiramate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-746 | TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20240727_f3321dc5-0fb7-0d12-e053-2a95a90a9694.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-746-26 | 51655074626 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-746-26) | 2023-01-05 | No | No | Historical |
| 51655-746-52 | 51655074652 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-746-52) | 2022-12-30 | No | No | Historical |