FDA.reportPublic FDA data

Topiramate

Product NDC
65862-173
11-digit product format
658620173
Labeler code
65862
Product ID
65862-173_67afee59-3d84-418f-832c-d00abd43fe5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078462
Marketing category
ANDA
Marketing start
2009-03-27
Substance
TOPIRAMATE
Active strength
100 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-173UNFINISHEDActive or certified unfinished drug listing2026-08-03
unfinished packagepackage65862-17365862-173-59UNFINISHEDActive or certified unfinished drug listing2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078462-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A078462-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A078462-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A078462-004TOPIRAMATETOPIRAMATE200MGTABLET / ORALAB2009-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A078462-001AB
A078462-002AB
A078462-003AB
A078462-004AB

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 22:54:322026-06A078462-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A078462-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A078462-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A078462-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078462-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078462-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078462-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078462-004AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.4833f2e8-16b7-406f-937a-55bc978bf92c2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078462
application number: ANDA078462
TopiramateTOPIRAMATEAurobindo Pharma Limited32b48ea0-a215-43b8-83b4-a5435a686d682026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078462
application number: ANDA078462
ndc (product): 65862-173
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.5424d59e-74f1-4c3c-b737-79e9776e0b602026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078462
application number: ANDA078462
TopiramateTOPIRAMATENCS HealthCare of KY, LLC dba Vangard Labs444464fb-6a95-4e10-99a7-fdbc7dbb4c482025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078462
application number: ANDA078462

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE100 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
151226Internal RxNorm lookup
199888Internal RxNorm lookup
199889Internal RxNorm lookup
199890Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
32b48ea0-a215-43b8-83b4-a5435a686d68Available 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
65862-173-05Topiramate500 in 1 BOTTLETABLET, FILM COATED50033
65862-173-60Topiramate60 in 1 BOTTLETABLET, FILM COATED6033
65862-173-99Topiramate1000 in 1 BOTTLETABLET, FILM COATED100033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-173-60EA - Each65862-173fde4166f-9dd7-48e5-a0b2-36c4e8e37a6f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-173TOPIRAMATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]31Current NDC, Legacy NDC, 3 package rows20250508_32b48ea0-a215-43b8-83b4-a5435a686d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN32b48ea0-a215-43b8-83b4-a5435a686d6833
199890topiramate 200 MG Oral TabletPSN32b48ea0-a215-43b8-83b4-a5435a686d6833
199888topiramate 25 MG Oral TabletPSN32b48ea0-a215-43b8-83b4-a5435a686d6833
151226topiramate 50 MG Oral TabletPSN32b48ea0-a215-43b8-83b4-a5435a686d6833
199889topiramate 100 MG Oral TabletSCD32b48ea0-a215-43b8-83b4-a5435a686d6833
199890topiramate 200 MG Oral TabletSCD32b48ea0-a215-43b8-83b4-a5435a686d6833
199888topiramate 25 MG Oral TabletSCD32b48ea0-a215-43b8-83b4-a5435a686d6833
151226topiramate 50 MG Oral TabletSCD32b48ea0-a215-43b8-83b4-a5435a686d6833
199889topiramate 100 MG Oral TabletPSN444464fb-6a95-4e10-99a7-fdbc7dbb4c481
199888topiramate 25 MG Oral TabletPSN444464fb-6a95-4e10-99a7-fdbc7dbb4c481
151226topiramate 50 MG Oral TabletPSN444464fb-6a95-4e10-99a7-fdbc7dbb4c481
199889topiramate 100 MG Oral TabletSCD444464fb-6a95-4e10-99a7-fdbc7dbb4c481
199888topiramate 25 MG Oral TabletSCD444464fb-6a95-4e10-99a7-fdbc7dbb4c481
151226topiramate 50 MG Oral TabletSCD444464fb-6a95-4e10-99a7-fdbc7dbb4c481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-173-0565862017305500 TABLET, FILM COATED in 1 BOTTLE (65862-173-05) 2022-04-110000-00-00NoNoCurrent
65862-173-59658620173595000 TABLET, FILM COATED in 1 BAG (65862-173-59)27-MAR-09Current
65862-173-606586201736060 TABLET, FILM COATED in 1 BOTTLE (65862-173-60) 2009-03-270000-00-00NoNoCurrent
65862-173-99658620173991000 TABLET, FILM COATED in 1 BOTTLE (65862-173-99) 2022-04-110000-00-00NoNoCurrent