FDA.reportPublic FDA data

Topiramate

Product NDC
0615-8138
11-digit product format
006158138
Labeler code
0615
Product ID
0615-8138_8346efad-e6ee-4384-b042-95683f943e8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077627
Marketing category
ANDA
Marketing start
2009-03-27
Marketing end
2026-07-31
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
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
excluded productproduct0615-8138DDiscontinued by firm2026-08-03
excluded packagepackage0615-81380615-8138-39DDiscontinued by firm2026-08-03

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
A077627-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A077627-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A077627-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A077627-004TOPIRAMATETOPIRAMATE200MGTABLET / 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
A077627-001AB
A077627-002AB
A077627-003AB
A077627-004AB

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 22:54:322026-06A077627-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A077627-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A077627-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A077627-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077627-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077627-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077627-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A077627-004AB1a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEREMEDYREPACK INC.610d4df7-703f-4070-9adc-3e57ca05a2f12026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
TopiramateTOPIRAMATEUnit Dose Solutions, Inc.562f3fec-489b-4662-e063-6294a90a4ea22026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
TopiramateTOPIRAMATEGlenmark Pharmaceuticals Inc., USA35312f49-decf-428d-bf5f-4215b762ed3c2026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
TopiramateTOPIRAMATENorthwind Health Company, LLCae63e0e2-ceb1-4cc7-88fa-92cfa45169602026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
TopiramateTOPIRAMATEREMEDYREPACK INC.3f99b26b-79b9-4efb-aa2c-2868e1e126c82025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
TopiramateTOPIRAMATEProficient Rx LPa712d050-d5de-4685-a80a-548ab080fdb72021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627
TopiramateTOPIRAMATEProficient Rx LP5d9b2c1d-565e-4c43-96ef-e5cd2593d0a82020-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077627
application number: ANDA077627

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
0615-8138-39Topiramate30 in 1 BLISTER PACKTABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8138TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]8Current NDC, Legacy NDC, 1 package rows20221220_b0036d28-ca99-42c6-81ad-3c93f4a844a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNb0036d28-ca99-42c6-81ad-3c93f4a844a19
199888topiramate 25 MG Oral TabletPSNb0036d28-ca99-42c6-81ad-3c93f4a844a19
151226topiramate 50 MG Oral TabletPSNb0036d28-ca99-42c6-81ad-3c93f4a844a19
199889topiramate 100 MG Oral TabletSCDb0036d28-ca99-42c6-81ad-3c93f4a844a19
199888topiramate 25 MG Oral TabletSCDb0036d28-ca99-42c6-81ad-3c93f4a844a19
151226topiramate 50 MG Oral TabletSCDb0036d28-ca99-42c6-81ad-3c93f4a844a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8138-390061581383930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8138-39) 2018-07-092026-07-31NoNoCurrent