FDA.reportPublic FDA data

QUDEXY

Product NDC
0245-1071
11-digit product format
002451071
Labeler code
0245
Product ID
0245-1071_c282e476-f752-48da-ae0f-2987d682a4b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA205122
Marketing category
NDA
Marketing start
2014-04-11
Substance
TOPIRAMATE
Active strength
25 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QUDEXY
Brand name suffix
XR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui1494766, 1494769, 1494771, 1494775, 1494778, 1494781, 1812419, 1812421, 1812425, 1812427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedcProduct name420260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077Product name220250623
cb966f54-bbf0-40fb-b581-80c6648d510cProduct name420250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193Product name420250305
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-1071-30QUDEXYXR30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3029
0245-1071-30QUDEXYXR1 in 1 CARTONCAPSULE, EXTENDED RELEASE129
0245-1071-90QUDEXYXR1 in 1 CARTONCAPSULE, EXTENDED RELEASE129
0245-1071-90QUDEXYXR90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-1071-15EA - Each0245-107121d2d7ab-f084-430f-9681-2acfdfd0820812014-07-02
0245-1071-30EA - Each0245-1071889056cc-73ad-4098-a439-0fbd6c268a7112014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TopiramateACTIVE INGREDIENT0H73WJJ391QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
TopiramateACTIVE MOIETY0H73WJJ391QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UQUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
diethyl phthalateINACTIVE INGREDIENTUF064M00AFQUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BQUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
ferric oxide redINACTIVE INGREDIENT1K09F3G675QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTQUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPQUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-1071QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]27Current NDC, Legacy NDC, 4 package rows20250519_46f54677-3a22-4c38-9b92-923020164e15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494766Qudexy XR 100 MG 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1494771Qudexy XR 150 MG 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1494775Qudexy XR 200 MG 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1494778Qudexy XR 25 MG 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1494781Qudexy XR 50 MG 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1812427topiramate 100 MG Sprinkle 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1494769topiramate 150 MG Sprinkle 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1812419topiramate 200 MG Sprinkle 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsulePSN46f54677-3a22-4c38-9b92-923020164e1529
1494766Sprinkle 24 HR topiramate 100 MG Extended Release Oral Capsule [Qudexy]SBD46f54677-3a22-4c38-9b92-923020164e1529
1494771Sprinkle 24 HR topiramate 150 MG Extended Release Oral Capsule [Qudexy]SBD46f54677-3a22-4c38-9b92-923020164e1529
1494775Sprinkle 24 HR topiramate 200 MG Extended Release Oral Capsule [Qudexy]SBD46f54677-3a22-4c38-9b92-923020164e1529
1494778Sprinkle 24 HR topiramate 25 MG Extended Release Oral Capsule [Qudexy]SBD46f54677-3a22-4c38-9b92-923020164e1529
1494781Sprinkle 24 HR topiramate 50 MG Extended Release Oral Capsule [Qudexy]SBD46f54677-3a22-4c38-9b92-923020164e1529
1812427Sprinkle 24 HR topiramate 100 MG Extended Release Oral CapsuleSCD46f54677-3a22-4c38-9b92-923020164e1529
1494769Sprinkle 24 HR topiramate 150 MG Extended Release Oral CapsuleSCD46f54677-3a22-4c38-9b92-923020164e1529
1812419Sprinkle 24 HR topiramate 200 MG Extended Release Oral CapsuleSCD46f54677-3a22-4c38-9b92-923020164e1529
1812421Sprinkle 24 HR topiramate 25 MG Extended Release Oral CapsuleSCD46f54677-3a22-4c38-9b92-923020164e1529
1812425Sprinkle 24 HR topiramate 50 MG Extended Release Oral CapsuleSCD46f54677-3a22-4c38-9b92-923020164e1529
1494766Qudexy XR 100 MG 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494766Qudexy XR 100 MG Sprinkle 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494771Qudexy XR 150 MG 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494771Qudexy XR 150 MG Sprinkle 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494775Qudexy XR 200 MG 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494775Qudexy XR 200 MG Sprinkle 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494778Qudexy XR 25 MG 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494778Qudexy XR 25 MG Sprinkle 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494781Qudexy XR 50 MG 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494781Qudexy XR 50 MG Sprinkle 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1812427topiramate 100 MG Sprinkle 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1494769topiramate 150 MG Sprinkle 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1812419topiramate 200 MG Sprinkle 24 HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsuleSY46f54677-3a22-4c38-9b92-923020164e1529

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0245-1071-30002451071301 BOTTLE in 1 CARTON (0245-1071-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2014-04-110000-00-00NoNoCurrent
0245-1071-90002451071901 BOTTLE in 1 CARTON (0245-1071-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2014-04-110000-00-00NoNoCurrent