topiramate
- Product NDC
- 70518-4515
- 11-digit product format
- 705184515
- Labeler code
- 70518
- Product ID
- 70518-4515_4d272d99-aebe-576f-e063-6394a90ae17b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2025-11-04
- 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 |
|---|
| 70518-4515-0 | topiramate | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 4 |
| 70518-4515-1 | topiramate | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 4 |
| 70518-4515-2 | topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 4 |
| 70518-4515-3 | topiramate | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4515-0 | 70518451500 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-0) | 2025-11-04 | No | No | Current |
| 70518-4515-1 | 70518451501 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4515-1) | 2025-12-04 | No | No | Current |
| 70518-4515-2 | 70518451502 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-2) | 2026-03-14 | No | No | Current |
| 70518-4515-3 | 70518451503 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-3) | 2026-03-16 | No | No | Current |