Topiramate
- Product NDC
- 70518-2391
- 11-digit product format
- 705182391
- Labeler code
- 70518
- Product ID
- 70518-2391_50acd061-175e-673b-e063-6294a90af801
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2019-10-28
- Substance
- TOPIRAMATE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 199890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2391-0 | Topiramate | 30 in 1 BOX | TABLET | 30 | | 11 |
| 70518-2391-1 | Topiramate | 1 in 1 POUCH | TABLET | 1 | | 11 |
| 70518-2391-2 | Topiramate | 30 in 1 BLISTER PACK | TABLET | 30 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2391 | TOPIRAMATE TABLET [REMEDYREPACK INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20250316_b71c09c5-43dd-4d98-9ab6-0b0c99908cac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2391-0 | 70518239100 | 30 POUCH in 1 BOX (70518-2391-0) / 1 TABLET in 1 POUCH (70518-2391-1) | 30 pouch | 2019-10-28 | 0000-00-00 | No | No | Current |
| 70518-2391-1 | 70518239101 | 1 in 1 POUCH | | | | | | Historical |
| 70518-2391-2 | 70518239102 | 30 TABLET in 1 BLISTER PACK (70518-2391-2) | 30 tablet | 2021-01-18 | 0000-00-00 | No | No | Current |