QUDEXY XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Topiramate.
Product ID | 0245-1072_14433503-965b-4450-b80c-2d4ed2fbd40a |
NDC | 0245-1072 |
Product Type | Human Prescription Drug |
Proprietary Name | QUDEXY XR |
Generic Name | Topiramate |
Dosage Form | Capsule, Extended Release |
Route of Administration | ORAL |
Marketing Start Date | 2014-04-11 |
Marketing Category | NDA / NDA |
Application Number | NDA205122 |
Labeler Name | Upsher-Smith Laboratories, LLC |
Substance Name | TOPIRAMATE |
Active Ingredient Strength | 50 mg/1 |
Pharm Classes | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2014-04-11 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA205122 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2014-04-11 |
Marketing End Date | 2017-04-13 |
Marketing Category | NDA |
Application Number | NDA205122 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2014-04-11 |
Marketing Category | NDA |
Application Number | NDA205122 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2014-04-11 |
Ingredient | Strength |
---|---|
TOPIRAMATE | 50 mg/1 |
SPL SET ID: | 46f54677-3a22-4c38-9b92-923020164e15 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
0245-1071 | QUDEXY | Topiramate |
0245-1072 | QUDEXY | Topiramate |
0245-1073 | QUDEXY | Topiramate |
0245-1074 | QUDEXY | Topiramate |
0245-1075 | QUDEXY | Topiramate |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUDEXY 86070577 4642351 Live/Registered |
Upsher-Smith Laboratories 2013-09-20 |