topiramate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Topiramate.
| Product ID | 68382-138_2597a79d-bdec-463e-b98f-75e61e24e060 |
| NDC | 68382-138 |
| Product Type | Human Prescription Drug |
| Proprietary Name | topiramate |
| Generic Name | Topiramate |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2009-03-27 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA078235 |
| Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
| Substance Name | TOPIRAMATE |
| Active Ingredient Strength | 25 mg/1 |
| Pharm Classes | Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2009-03-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA078235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-03-27 |
| Marketing Category | ANDA |
| Application Number | ANDA078235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-03-27 |
| Marketing Category | ANDA |
| Application Number | ANDA078235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-03-27 |
| Marketing Category | ANDA |
| Application Number | ANDA078235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-03-27 |
| Ingredient | Strength |
|---|---|
| TOPIRAMATE | 25 mg/1 |
| SPL SET ID: | 67dcdd6e-48bc-418e-a887-805929d83ce0 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-7335 | Topiramate | Topiramate |
| 0093-7336 | Topiramate | Topiramate |
| 0615-7562 | Topiramate | Topiramate |
| 0615-7563 | Topiramate | Topiramate |
| 0615-7564 | Topiramate | Topiramate |
| 0615-7565 | Topiramate | Topiramate |
| 0615-8138 | Topiramate | Topiramate |
| 0615-8139 | Topiramate | Topiramate |
| 68071-3012 | Topiramate | Topiramate |
| 68071-3088 | Topiramate | Topiramate |
| 68071-3196 | Topiramate | Topiramate |
| 68071-1960 | Topiramate | Topiramate |
| 68071-1971 | Topiramate | Topiramate |
| 68071-1900 | Topiramate | Topiramate |
| 68071-4793 | topiramate | topiramate |
| 68071-4760 | topiramate | topiramate |
| 68084-344 | Topiramate | Topiramate |
| 68084-342 | Topiramate | Topiramate |
| 68071-4756 | topiramate | topiramate |
| 68084-345 | Topiramate | Topiramate |
| 68258-7159 | TOPIRAMATE | TOPIRAMATE |
| 68382-138 | topiramate | topiramate |
| 68382-004 | topiramate | topiramate |
| 68258-3000 | TOPIRAMATE | TOPIRAMATE |
| 68258-3002 | TOPIRAMATE | TOPIRAMATE |
| 68258-3001 | TOPIRAMATE | TOPIRAMATE |
| 68382-139 | topiramate | topiramate |
| 68258-7056 | TOPIRAMATE | TOPIRAMATE |
| 68382-140 | topiramate | topiramate |
| 68382-005 | topiramate | topiramate |
| 68258-7156 | TOPIRAMATE | TOPIRAMATE |
| 68382-141 | topiramate | topiramate |
| 68382-769 | Topiramate | Topiramate |
| 68382-864 | Topiramate | Topiramate |
| 68387-559 | Topiramate | Topiramate |
| 68387-558 | Topiramate | Topiramate |
| 68387-560 | Topiramate | Topiramate |
| 68382-863 | Topiramate | Topiramate |
| 68462-109 | Topiramate | Topiramate |
| 68462-110 | Topiramate | Topiramate |
| 68462-108 | Topiramate | Topiramate |
| 68462-153 | Topiramate | Topiramate |
| 68788-6435 | Topiramate | Topiramate |
| 68788-7016 | Topiramate | Topiramate |
| 68788-6377 | Topiramate | Topiramate |
| 68788-6770 | Topiramate | Topiramate |
| 68788-7351 | topiramate | topiramate |
| 68788-8965 | Topiramate | Topiramate |
| 68788-6366 | Topiramate | Topiramate |
| 68788-6916 | Topiramate | Topiramate |