TOPIRAMATE
- Product NDC
- 13668-033
- 11-digit product format
- 136680033
- Labeler code
- 13668
- Product ID
- 13668-033_16ea5453-3213-4fef-9918-92f5c7179798
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA079153
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13668-033-01 | EA - Each | 13668-033 | 651dde5d-6e53-4c77-8270-699106da6305 | 1 | 2012-07-24 |
| 13668-033-05 | EA - Each | 13668-033 | de867dd9-963d-401f-b806-1f271a14af65 | 1 | 2012-07-24 |
| 13668-033-60 | EA - Each | 13668-033 | fed986bf-73c7-4385-8e5b-c832f1d117d3 | 1 | 2012-07-24 |
| 13668-033-64 | EA - Each | 13668-033 | 5a669728-2f9e-4934-b467-e14fa47f2ca3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199889 | topiramate 100 MG Oral Tablet | PSN | efd1106b-d369-4651-b703-b0985ce93b79 | 3 |
| 199888 | topiramate 25 MG Oral Tablet | PSN | efd1106b-d369-4651-b703-b0985ce93b79 | 3 |
| 151226 | topiramate 50 MG Oral Tablet | PSN | efd1106b-d369-4651-b703-b0985ce93b79 | 3 |
| 199889 | topiramate 100 MG Oral Tablet | SCD | efd1106b-d369-4651-b703-b0985ce93b79 | 3 |
| 199888 | topiramate 25 MG Oral Tablet | SCD | efd1106b-d369-4651-b703-b0985ce93b79 | 3 |
| 151226 | topiramate 50 MG Oral Tablet | SCD | efd1106b-d369-4651-b703-b0985ce93b79 | 3 |
| 199889 | topiramate 100 MG Oral Tablet | PSN | 0f686676-8d66-4f29-966c-0a31e2eee90c | 1 |
| 199889 | topiramate 100 MG Oral Tablet | SCD | 0f686676-8d66-4f29-966c-0a31e2eee90c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 13668-033-01 | 13668003301 | 100 TABLET in 1 BOTTLE (13668-033-01) | 100 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-033-05 | 13668003305 | 500 TABLET in 1 BOTTLE (13668-033-05) | 500 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-033-31 | 13668003331 | 2500 TABLET in 1 BOTTLE (13668-033-31) | 2500 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-033-60 | 13668003360 | 60 TABLET in 1 BOTTLE (13668-033-60) | 60 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-033-64 | 13668003364 | 90 TABLET in 1 DOSE PACK (13668-033-64) | 90 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |