topiramate is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Topiramate.
Product ID | 65841-651_2ad38c27-f036-4997-93db-8ce5327c58fc |
NDC | 65841-651 |
Product Type | Human Prescription Drug |
Proprietary Name | topiramate |
Generic Name | Topiramate |
Dosage Form | Capsule, Coated Pellets |
Route of Administration | ORAL |
Marketing Start Date | 2009-10-14 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA078877 |
Labeler Name | Cadila Healthcare Limited |
Substance Name | TOPIRAMATE |
Active Ingredient Strength | 15 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 | 2020-12-31 |
Marketing Start Date | 2009-10-14 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA078877 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2009-10-14 |
Marketing Category | ANDA |
Application Number | ANDA078877 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2009-10-14 |
Marketing Category | ANDA |
Application Number | ANDA078877 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2009-10-14 |
Marketing Category | ANDA |
Application Number | ANDA078877 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2009-10-14 |
Marketing Category | ANDA |
Application Number | ANDA078877 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2009-10-14 |
Ingredient | Strength |
---|---|
TOPIRAMATE | 15 mg/1 |
SPL SET ID: | 6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
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 |