Home NDC 0245-1071 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205122-001 QUDEXY XR TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2014-03-11 N205122-002 QUDEXY XR TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2014-03-11 N205122-003 QUDEXY XR TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2014-03-11 N205122-004 QUDEXY XR TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2014-03-11 N205122-005 QUDEXY XR TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD, RS 2014-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 25 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N205122-001 QUDEXY XR 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2014-03-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-002 QUDEXY XR 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2014-03-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-003 QUDEXY XR 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2014-03-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-004 QUDEXY XR 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2014-03-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-005 QUDEXY XR 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD, RS 2014-03-11 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N205122-001 10363224 2033-03-19 U-766 2019-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-001 8652527 2033-03-19 Drug product 2014-03-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-001 8889190 2033-03-19 Drug product 2014-11-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-001 9101545 2033-03-19 Drug product 2015-08-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-001 9555005 2033-03-19 Drug product 2017-02-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-002 10363224 2033-03-19 U-766 2019-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-002 8652527 2033-03-19 Drug product 2014-03-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-002 8889190 2033-03-19 Drug product 2014-11-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-002 9101545 2033-03-19 Drug product 2015-08-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-002 9555005 2033-03-19 Drug product 2017-02-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-003 10363224 2033-03-19 U-766 2019-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-003 8652527 2033-03-19 Drug product 2014-03-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-003 8889190 2033-03-19 Drug product 2014-11-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-003 9101545 2033-03-19 Drug product 2015-08-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-003 9555005 2033-03-19 Drug product 2017-02-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-004 10363224 2033-03-19 U-766 2019-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-004 8652527 2033-03-19 Drug product 2014-03-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-004 8889190 2033-03-19 Drug product 2014-11-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-004 9101545 2033-03-19 Drug product 2015-08-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-004 9555005 2033-03-19 Drug product 2017-02-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-005 10363224 2033-03-19 U-766 2019-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-005 8652527 2033-03-19 Drug product 2014-03-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-005 8889190 2033-03-19 Drug product 2014-11-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-005 9101545 2033-03-19 Drug product 2015-08-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N205122-005 9555005 2033-03-19 Drug product 2017-02-02 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base QUDEXY
Brand name suffix XR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0H73WJJ391 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1494766 Internal RxNorm lookup 1494769 Internal RxNorm lookup 1494771 Internal RxNorm lookup 1494775 Internal RxNorm lookup 1494778 Internal RxNorm lookup 1494781 Internal RxNorm lookup 1812419 Internal RxNorm lookup 1812421 Internal RxNorm lookup 1812425 Internal RxNorm lookup 1812427 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0245-1071-30 QUDEXYXR 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 29 0245-1071-30 QUDEXYXR 1 in 1 CARTON CAPSULE, EXTENDED RELEASE 1 29 0245-1071-90 QUDEXYXR 1 in 1 CARTON CAPSULE, EXTENDED RELEASE 1 29 0245-1071-90 QUDEXYXR 90 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 90 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Topiramate ACTIVE INGREDIENT 0H73WJJ391 QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6 Topiramate ACTIVE MOIETY 0H73WJJ391 QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6 diethyl phthalate INACTIVE INGREDIENT UF064M00AF QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6 ethylcelluloses INACTIVE INGREDIENT 7Z8S9VYZ4B QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6 hypromellose 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0245-1071 QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC] 27 Current NDC, Legacy NDC, 4 package rows 20250519_46f54677-3a22-4c38-9b92-923020164e15.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0245-1071-30 00245107130 1 BOTTLE in 1 CARTON (0245-1071-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 1 bottle 2014-04-11 0000-00-00 No No Current 0245-1071-90 00245107190 1 BOTTLE in 1 CARTON (0245-1071-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 1 bottle 2014-04-11 0000-00-00 No No Current