NDC 0245-1074

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 ID: 0245-1074_14433503-965b-4450-b80c-2d4ed2fbd40a
• NDC: 0245-1074
• 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: 100 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

Packaging

NDC 0245-1074-30

1 BOTTLE in 1 CARTON (0245-1074-30) > 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

• Marketing Start Date: 2014-04-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0245-1074-30 [00245107430]

QUDEXY XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA205122
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-11

NDC 0245-1074-15 [00245107415]

QUDEXY XR CAPSULE, EXTENDED RELEASE

• 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

NDC 0245-1074-90 [00245107490]

QUDEXY XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA205122
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-11

Drug Details

Active Ingredients

Ingredient	Strength
TOPIRAMATE	100 mg/1

OpenFDA Data

• SPL SET ID: 46f54677-3a22-4c38-9b92-923020164e15
• Manufacturer:
  • Upsher-Smith Laboratories, LLC
• UNII:
  • 0H73WJJ391
• 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"

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