topiramate
- Product NDC
- 70518-0233
- 11-digit product format
- 705180233
- Labeler code
- 70518
- Product ID
- 70518-0233_522c8964-07ca-51a9-e063-6394a90ade83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2017-02-16
- 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
- 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 | 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 |
|---|
| 70518-0233-0 | topiramate | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-0233 | TOPIRAMATE TABLET, FILM COATED [REMEDYREPACK INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20250425_5ce65b7f-9215-47a8-a784-f87a810bd7e4.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 |
|---|
| 70518-0233-0 | 70518023300 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0233-0) | 2017-02-16 | 0000-00-00 | No | No | Current |