topiramate
- Product NDC
- 70518-4247
- 11-digit product format
- 705184247
- Labeler code
- 70518
- Product ID
- 70518-4247_4007f7c8-71c9-60db-e063-6294a90aab3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078877
- Marketing category
- ANDA
- Marketing start
- 2024-12-24
- 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
- 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 205315 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4247-0 | topiramate | 30 in 1 BOX | CAPSULE, COATED PELLETS | 30 | | 3 |
| 70518-4247-1 | topiramate | 1 in 1 POUCH | CAPSULE, COATED PELLETS | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4247 | TOPIRAMATE CAPSULE, COATED PELLETS [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20250101_0c0a6774-e234-47a5-866e-462cfd99744c.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 |
|---|
| 70518-4247-0 | 70518424700 | 30 POUCH in 1 BOX (70518-4247-0) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-4247-1) | 30 pouch | 2024-12-24 | No | No | Historical |
| 70518-4247-1 | 70518424701 | 1 in 1 POUCH | | | | | Historical |