qudexy xr

Generic: topiramate

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name qudexy xr
Generic Name topiramate
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

topiramate 100 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0245-1074
Product ID 0245-1074_374eeb55-b017-48fd-e063-6294a90a6ad7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205122
Listing Expiration 2026-12-31
Marketing Start 2014-04-11

Pharmacologic Class

Mechanism of Action
cytochrome p450 3a4 inducers [moa] cytochrome p450 2c19 inhibitors [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02451074
Hyphenated Format 0245-1074

Supplemental Identifiers

RxCUI
1494766 1494769 1494771 1494775 1494778 1494781 1812419 1812421 1812425 1812427
UPC
0302451072309
UNII
0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name qudexy xr (source: ndc)
Generic Name topiramate (source: ndc)
Application Number NDA205122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0245-1074-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0245-1074-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

0245-1074-30 1 BOTTLE in 1 CARTON (0245-1074-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 0245-1074-90 1 BOTTLE in 1 CARTON (0245-1074-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

topiramate (100 mg/1)

Linked Drug Pages (1)

QUDEXY XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "374eeb55-b017-48fd-e063-6294a90a6ad7", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0302451072309"], "unii": ["0H73WJJ391"], "rxcui": ["1494766", "1494769", "1494771", "1494775", "1494778", "1494781", "1812419", "1812421", "1812425", "1812427"], "spl_set_id": ["46f54677-3a22-4c38-9b92-923020164e15"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0245-1074-30)  / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "0245-1074-30", "marketing_start_date": "20140411"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0245-1074-90)  / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "0245-1074-90", "marketing_start_date": "20140411"}], "brand_name": "QUDEXY XR", "product_id": "0245-1074_374eeb55-b017-48fd-e063-6294a90a6ad7", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0245-1074", "generic_name": "Topiramate", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QUDEXY", "brand_name_suffix": "XR", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "NDA205122", "marketing_category": "NDA", "marketing_start_date": "20140411", "listing_expiration_date": "20261231"}