TOPIRAMATE
- Product NDC
- 31722-547
- 11-digit product format
- 317220547
- Labeler code
- 31722
- Product ID
- 31722-547_c4f0c0d0-430f-4c9d-96f0-8c90f6af31e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA217443
- Marketing category
- ANDA
- Marketing start
- 2026-04-01
- 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 |
|---|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0H73WJJ391 |
| Rxcui | 1436239, 1437278, 1437283, 1437288 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e5b1b0ba-27f8-4d5d-8943-8aed080fdedc | Product name | 4 | 20260306 |
| 6c26dd6d-01b5-4a80-b096-b3a6f7ca6077 | Product name | 2 | 20250623 |
| cb966f54-bbf0-40fb-b581-80c6648d510c | Product name | 4 | 20250623 |
| 6e2fb0d7-40d7-e97c-1375-fa022ff20193 | Product name | 4 | 20250305 |
| 3d272a3f-17c0-421d-bc43-3cbdb719258d | Product name | 1 | 20250303 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31722-547-30 | TOPIRAMATE | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1437283 | topiramate 100 MG 24HR Extended Release Oral Capsule | PSN | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1437288 | topiramate 200 MG 24HR Extended Release Oral Capsule | PSN | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1437278 | topiramate 25 MG 24HR Extended Release Oral Capsule | PSN | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1436239 | topiramate 50 MG 24HR Extended Release Oral Capsule | PSN | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1437283 | 24 HR topiramate 100 MG Extended Release Oral Capsule | SCD | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1437288 | 24 HR topiramate 200 MG Extended Release Oral Capsule | SCD | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1437278 | 24 HR topiramate 25 MG Extended Release Oral Capsule | SCD | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1436239 | 24 HR topiramate 50 MG Extended Release Oral Capsule | SCD | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1437283 | topiramate 100 MG 24 HR Extended Release Oral Capsule | SY | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1437288 | topiramate 200 MG 24 HR Extended Release Oral Capsule | SY | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1437278 | topiramate 25 MG 24 HR Extended Release Oral Capsule | SY | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
| 1436239 | topiramate 50 MG 24 HR Extended Release Oral Capsule | SY | dbc52b16-b93d-4d83-942b-485c502db1fa | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 31722-547-30 | 31722054730 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-547-30) | 2026-04-01 | No | No | Current |