NDC 0245-1071

QUDEXY XR

Topiramate

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 ID0245-1071_14433503-965b-4450-b80c-2d4ed2fbd40a
NDC0245-1071
Product TypeHuman Prescription Drug
Proprietary NameQUDEXY XR
Generic NameTopiramate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-04-11
Marketing CategoryNDA / NDA
Application NumberNDA205122
Labeler NameUpsher-Smith Laboratories, LLC
Substance NameTOPIRAMATE
Active Ingredient Strength25 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0245-1071-30

1 BOTTLE in 1 CARTON (0245-1071-30) > 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2014-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0245-1071-15 [00245107115]

QUDEXY XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA205122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-11
Marketing End Date2017-04-13

NDC 0245-1071-90 [00245107190]

QUDEXY XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA205122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-11

NDC 0245-1071-30 [00245107130]

QUDEXY XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA205122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-11

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE25 mg/1

OpenFDA Data

SPL SET ID:46f54677-3a22-4c38-9b92-923020164e15
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1812419
  • 1494771
  • 1494781
  • 1494775
  • 1494769
  • 1494766
  • 1494778
  • 1812421
  • 1812427
  • 1812425
  • UPC Code
  • 0302451073306
  • 0302451074303
  • 0302451075300
  • 0302451072309
  • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]

    NDC Crossover Matching brand name "QUDEXY XR" or generic name "Topiramate"

    NDCBrand NameGeneric Name
    0245-1071QUDEXYTopiramate
    0245-1072QUDEXYTopiramate
    0245-1073QUDEXYTopiramate
    0245-1074QUDEXYTopiramate
    0245-1075QUDEXYTopiramate
    0093-7335TopiramateTopiramate
    0093-7336TopiramateTopiramate
    0615-7562TopiramateTopiramate
    0615-7563TopiramateTopiramate
    0615-7564TopiramateTopiramate
    0615-7565TopiramateTopiramate
    0615-8138TopiramateTopiramate
    0615-8139TopiramateTopiramate

    Trademark Results [QUDEXY]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    QUDEXY
    QUDEXY
    86070577 4642351 Live/Registered
    Upsher-Smith Laboratories
    2013-09-20

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