FDA.reportPublic FDA data

Topiramate

Product NDC
0832-1071
11-digit product format
008321071
Labeler code
0832
Product ID
0832-1071_4c23c6e3-1684-b1fd-e063-6394a90a99a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA205122
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-07-07
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205122-001QUDEXY XRTOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD2014-03-11
N205122-002QUDEXY XRTOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD2014-03-11
N205122-003QUDEXY XRTOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD2014-03-11
N205122-004QUDEXY XRTOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD2014-03-11
N205122-005QUDEXY XRTOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD, RS2014-03-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N205122-001AB2
N205122-002AB2
N205122-003AB2
N205122-004AB2
N205122-005AB2

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205122-001103632242033-03-19U-7662019-08-06
N205122-00186525272033-03-19Drug product2014-03-12
N205122-00188891902033-03-19Drug product2014-11-18
N205122-00191015452033-03-19Drug product2015-08-11
N205122-00195550052033-03-19Drug product2017-02-02
N205122-002103632242033-03-19U-7662019-08-06
N205122-00286525272033-03-19Drug product2014-03-12
N205122-00288891902033-03-19Drug product2014-11-18
N205122-00291015452033-03-19Drug product2015-08-11
N205122-00295550052033-03-19Drug product2017-02-02
N205122-003103632242033-03-19U-7662019-08-06
N205122-00386525272033-03-19Drug product2014-03-12
N205122-00388891902033-03-19Drug product2014-11-18
N205122-00391015452033-03-19Drug product2015-08-11
N205122-00395550052033-03-19Drug product2017-02-02
N205122-004103632242033-03-19U-7662019-08-06
N205122-00486525272033-03-19Drug product2014-03-12
N205122-00488891902033-03-19Drug product2014-11-18
N205122-00491015452033-03-19Drug product2015-08-11
N205122-00495550052033-03-19Drug product2017-02-02
N205122-005103632242033-03-19U-7662019-08-06
N205122-00586525272033-03-19Drug product2014-03-12
N205122-00588891902033-03-19Drug product2014-11-18
N205122-00591015452033-03-19Drug product2015-08-11
N205122-00595550052033-03-19Drug product2017-02-02

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N205122-001QUDEXY XR25MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD2014-03-11a50c72e98297…
2026-08-01 22:54:322026-06N205122-002QUDEXY XR50MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD2014-03-11a50c72e98297…
2026-08-01 22:54:322026-06N205122-003QUDEXY XR100MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD2014-03-11a50c72e98297…
2026-08-01 22:54:322026-06N205122-004QUDEXY XR150MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD2014-03-11a50c72e98297…
2026-08-01 22:54:322026-06N205122-005QUDEXY XR200MGCAPSULE, EXTENDED RELEASE / ORALAB2RLD, RS2014-03-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N205122-001AB21a50c72e98297…
2026-08-01 22:54:322026-06N205122-002AB21a50c72e98297…
2026-08-01 22:54:322026-06N205122-003AB21a50c72e98297…
2026-08-01 22:54:322026-06N205122-004AB21a50c72e98297…
2026-08-01 22:54:322026-06N205122-005AB21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N205122-001103632242033-03-19U-7662019-08-06a50c72e98297…
2026-08-01 22:54:322026-06N205122-00186525272033-03-19Drug product2014-03-12a50c72e98297…
2026-08-01 22:54:322026-06N205122-00188891902033-03-19Drug product2014-11-18a50c72e98297…
2026-08-01 22:54:322026-06N205122-00191015452033-03-19Drug product2015-08-11a50c72e98297…
2026-08-01 22:54:322026-06N205122-00195550052033-03-19Drug product2017-02-02a50c72e98297…
2026-08-01 22:54:322026-06N205122-002103632242033-03-19U-7662019-08-06a50c72e98297…
2026-08-01 22:54:322026-06N205122-00286525272033-03-19Drug product2014-03-12a50c72e98297…
2026-08-01 22:54:322026-06N205122-00288891902033-03-19Drug product2014-11-18a50c72e98297…
2026-08-01 22:54:322026-06N205122-00291015452033-03-19Drug product2015-08-11a50c72e98297…
2026-08-01 22:54:322026-06N205122-00295550052033-03-19Drug product2017-02-02a50c72e98297…
2026-08-01 22:54:322026-06N205122-003103632242033-03-19U-7662019-08-06a50c72e98297…
2026-08-01 22:54:322026-06N205122-00386525272033-03-19Drug product2014-03-12a50c72e98297…
2026-08-01 22:54:322026-06N205122-00388891902033-03-19Drug product2014-11-18a50c72e98297…
2026-08-01 22:54:322026-06N205122-00391015452033-03-19Drug product2015-08-11a50c72e98297…
2026-08-01 22:54:322026-06N205122-00395550052033-03-19Drug product2017-02-02a50c72e98297…
2026-08-01 22:54:322026-06N205122-004103632242033-03-19U-7662019-08-06a50c72e98297…
2026-08-01 22:54:322026-06N205122-00486525272033-03-19Drug product2014-03-12a50c72e98297…
2026-08-01 22:54:322026-06N205122-00488891902033-03-19Drug product2014-11-18a50c72e98297…
2026-08-01 22:54:322026-06N205122-00491015452033-03-19Drug product2015-08-11a50c72e98297…
2026-08-01 22:54:322026-06N205122-00495550052033-03-19Drug product2017-02-02a50c72e98297…
2026-08-01 22:54:322026-06N205122-005103632242033-03-19U-7662019-08-06a50c72e98297…
2026-08-01 22:54:322026-06N205122-00586525272033-03-19Drug product2014-03-12a50c72e98297…
2026-08-01 22:54:322026-06N205122-00588891902033-03-19Drug product2014-11-18a50c72e98297…
2026-08-01 22:54:322026-06N205122-00591015452033-03-19Drug product2015-08-11a50c72e98297…
2026-08-01 22:54:322026-06N205122-00595550052033-03-19Drug product2017-02-02a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUDEXY XRTOPIRAMATEUpsher-Smith Laboratories, LLC46f54677-3a22-4c38-9b92-923020164e152026-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 205122
application number: NDA205122
TopiramateTOPIRAMATEUpsher-Smith Laboratories, LLC691d276c-9cc1-4d39-828f-0f44d7ef63282026-03-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 205122
application number: NDA205122
ndc (product): 0832-1071

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0H73WJJ391Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1494769Internal RxNorm lookup
1812419Internal RxNorm lookup
1812421Internal RxNorm lookup
1812425Internal RxNorm lookup
1812427Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
691d276c-9cc1-4d39-828f-0f44d7ef6328Available on FDA.report

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
0832-1071-15Topiramate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50022
0832-1071-30Topiramate1 in 1 CARTONCAPSULE, EXTENDED RELEASE122
0832-1071-30Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3022
0832-1071-90Topiramate1 in 1 CARTONCAPSULE, EXTENDED RELEASE122
0832-1071-90Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-1071-15EA - Each0832-1071686dbbb9-4521-44f0-9ffe-4cfefe408f1e12014-08-01
0832-1071-30EA - Each0832-107156d33631-87bf-4ec0-9cd1-b2c72ffbda3e12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TopiramateACTIVE INGREDIENT0H73WJJ391TOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
TopiramateACTIVE MOIETY0H73WJJ391TOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
diethyl phthalateINACTIVE INGREDIENTUF064M00AFTOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
ethylcellulose (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62TOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
ferric oxide redINACTIVE INGREDIENT1K09F3G675TOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1071TOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]20Current NDC, Legacy NDC, 5 package rows20250429_691d276c-9cc1-4d39-828f-0f44d7ef6328.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812427topiramate 100 MG Sprinkle 24HR Extended Release Oral CapsulePSN691d276c-9cc1-4d39-828f-0f44d7ef632822
1494769topiramate 150 MG Sprinkle 24HR Extended Release Oral CapsulePSN691d276c-9cc1-4d39-828f-0f44d7ef632822
1812419topiramate 200 MG Sprinkle 24HR Extended Release Oral CapsulePSN691d276c-9cc1-4d39-828f-0f44d7ef632822
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsulePSN691d276c-9cc1-4d39-828f-0f44d7ef632822
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsulePSN691d276c-9cc1-4d39-828f-0f44d7ef632822
1812427Sprinkle 24 HR topiramate 100 MG Extended Release Oral CapsuleSCD691d276c-9cc1-4d39-828f-0f44d7ef632822
1494769Sprinkle 24 HR topiramate 150 MG Extended Release Oral CapsuleSCD691d276c-9cc1-4d39-828f-0f44d7ef632822
1812419Sprinkle 24 HR topiramate 200 MG Extended Release Oral CapsuleSCD691d276c-9cc1-4d39-828f-0f44d7ef632822
1812421Sprinkle 24 HR topiramate 25 MG Extended Release Oral CapsuleSCD691d276c-9cc1-4d39-828f-0f44d7ef632822
1812425Sprinkle 24 HR topiramate 50 MG Extended Release Oral CapsuleSCD691d276c-9cc1-4d39-828f-0f44d7ef632822
1812427topiramate 100 MG Sprinkle 24 HR Extended Release Oral CapsuleSY691d276c-9cc1-4d39-828f-0f44d7ef632822
1494769topiramate 150 MG Sprinkle 24 HR Extended Release Oral CapsuleSY691d276c-9cc1-4d39-828f-0f44d7ef632822
1812419topiramate 200 MG Sprinkle 24 HR Extended Release Oral CapsuleSY691d276c-9cc1-4d39-828f-0f44d7ef632822
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsuleSY691d276c-9cc1-4d39-828f-0f44d7ef632822
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsuleSY691d276c-9cc1-4d39-828f-0f44d7ef632822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-1071-1500832107115500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-1071-15) 2014-07-070000-00-00NoNoCurrent
0832-1071-30008321071301 BOTTLE in 1 CARTON (0832-1071-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2014-07-070000-00-00NoNoCurrent
0832-1071-90008321071901 BOTTLE in 1 CARTON (0832-1071-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2014-07-070000-00-00NoNoCurrent