Topiramate
- Product NDC
- 27241-297
- 11-digit product format
- 272410297
- Labeler code
- 27241
- Product ID
- 27241-297_27efc40f-ad43-440f-936b-7013d92b56fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA219564
- Marketing category
- ANDA
- Marketing start
- 2025-09-02
- 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
- 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 | 50 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0H73WJJ391 |
| Rxcui | 1494769, 1812419, 1812421, 1812425, 1812427 |
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 |
|---|---|---|---|---|---|---|
| 27241-297-30 | Topiramate | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 5 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1812427 | topiramate 100 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1494769 | topiramate 150 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812419 | topiramate 200 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812421 | topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812425 | topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812427 | Sprinkle 24 HR topiramate 100 MG Extended Release Oral Capsule | SCD | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1494769 | Sprinkle 24 HR topiramate 150 MG Extended Release Oral Capsule | SCD | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812419 | Sprinkle 24 HR topiramate 200 MG Extended Release Oral Capsule | SCD | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812421 | Sprinkle 24 HR topiramate 25 MG Extended Release Oral Capsule | SCD | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812425 | Sprinkle 24 HR topiramate 50 MG Extended Release Oral Capsule | SCD | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812427 | topiramate 100 MG Sprinkle 24 HR Extended Release Oral Capsule | SY | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1494769 | topiramate 150 MG Sprinkle 24 HR Extended Release Oral Capsule | SY | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812419 | topiramate 200 MG Sprinkle 24 HR Extended Release Oral Capsule | SY | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812421 | topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule | SY | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
| 1812425 | topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule | SY | 813f5fe2-df82-479c-8014-d503ff5df52b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 27241-297-30 | 27241029730 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-297-30) | 2025-09-02 | No | No | Current |