Topiramate
- Product NDC
- 70518-4340
- 11-digit product format
- 705184340
- Labeler code
- 70518
- Product ID
- 70518-4340_3ba02ab7-e19a-6da4-e063-6394a90af058
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077627
- Marketing category
- ANDA
- Marketing start
- 2025-05-15
- 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 |
|---|
| 70518-4340-0 | Topiramate | 100 in 1 BOX | TABLET, FILM COATED | 100 | | 2 |
| 70518-4340-1 | Topiramate | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 2 |
| 70518-4340-2 | Topiramate | 30 in 1 BOX | TABLET, FILM COATED | 30 | | 2 |
| 70518-4340-3 | Topiramate | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4340 | TOPIRAMATE TABLET, FILM COATED [REMEDYREPACK INC.] | 1 | Current NDC, 4 package rows | 20250523_3f99b26b-79b9-4efb-aa2c-2868e1e126c8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4340-0 | 70518434000 | 100 POUCH in 1 BOX (70518-4340-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4340-1) | 100 pouch | 2025-05-15 | No | No | Historical |
| 70518-4340-1 | 70518434001 | 1 in 1 POUCH | | | | | Historical |
| 70518-4340-2 | 70518434002 | 30 POUCH in 1 BOX (70518-4340-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4340-3) | 30 pouch | 2025-06-09 | No | No | Historical |
| 70518-4340-3 | 70518434003 | 1 in 1 POUCH | | | | | Historical |