FDA.reportPublic FDA data

Topiramate

Product NDC
42291-958
11-digit product format
422910958
Labeler code
42291
Product ID
42291-958_48c104bb-d8d9-2940-e063-6394a90aeab3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA206210
Marketing category
ANDA
Marketing start
2024-10-30
Substance
TOPIRAMATE
Active strength
200 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206210-001TOPIRAMATETOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12023-03-10
A206210-002TOPIRAMATETOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12023-03-10
A206210-003TOPIRAMATETOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12023-03-10
A206210-004TOPIRAMATETOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206210-001AB1
A206210-002AB1
A206210-003AB1
A206210-004AB1

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 22:54:322026-06A206210-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12023-03-10a50c72e98297…
2026-08-01 22:54:322026-06A206210-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12023-03-10a50c72e98297…
2026-08-01 22:54:322026-06A206210-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12023-03-10a50c72e98297…
2026-08-01 22:54:322026-06A206210-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-03-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206210-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A206210-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A206210-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A206210-004AB11a50c72e98297…

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
TopiramateTOPIRAMATETeva Pharmaceuticals, Inc.4f20155f-05b9-40ec-af34-3b58aa8d60d42026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206210
application number: ANDA206210
TopiramateTOPIRAMATEAvKARE25b377f7-ea89-fb56-e063-6394a90a239d2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206210
application number: ANDA206210
ndc (product): 42291-958

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE200 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
1436239Internal RxNorm lookup
1437278Internal RxNorm lookup
1437283Internal RxNorm lookup
1437288Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25b377f7-ea89-fb56-e063-6394a90a239dAvailable 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
42291-958-30Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-958-30EA - Each42291-958ae24fa42-b85b-4e65-abbd-64058c18c0e712024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-958TOPIRAMATE CAPSULE, EXTENDED RELEASE [AVKARE]1Current NDC, 1 package rows20241101_25b377f7-ea89-fb56-e063-6394a90a239d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSN25b377f7-ea89-fb56-e063-6394a90a239d2
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSN25b377f7-ea89-fb56-e063-6394a90a239d2
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSN25b377f7-ea89-fb56-e063-6394a90a239d2
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSN25b377f7-ea89-fb56-e063-6394a90a239d2
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCD25b377f7-ea89-fb56-e063-6394a90a239d2
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCD25b377f7-ea89-fb56-e063-6394a90a239d2
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCD25b377f7-ea89-fb56-e063-6394a90a239d2
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCD25b377f7-ea89-fb56-e063-6394a90a239d2
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSY25b377f7-ea89-fb56-e063-6394a90a239d2
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSY25b377f7-ea89-fb56-e063-6394a90a239d2
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSY25b377f7-ea89-fb56-e063-6394a90a239d2
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSY25b377f7-ea89-fb56-e063-6394a90a239d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-958-304229109583030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-958-30) 2024-10-30NoNoCurrent