FDA.reportPublic FDA data

Topiramate

Product NDC
27241-297
11-digit product format
272410297
Labeler code
27241
Product ID
27241-297_27efc40f-ad43-440f-936b-7013d92b56fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA219564
Marketing category
ANDA
Marketing start
2025-09-02
Substance
TOPIRAMATE
Active strength
50 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
A219564-001TOPIRAMATETOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02
A219564-002TOPIRAMATETOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02
A219564-003TOPIRAMATETOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02
A219564-004TOPIRAMATETOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02
A219564-005TOPIRAMATETOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219564-001AB2
A219564-002AB2
A219564-003AB2
A219564-004AB2
A219564-005AB2

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 22:54:322026-06A219564-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02a50c72e98297…
2026-08-01 22:54:322026-06A219564-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02a50c72e98297…
2026-08-01 22:54:322026-06A219564-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02a50c72e98297…
2026-08-01 22:54:322026-06A219564-004TOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02a50c72e98297…
2026-08-01 22:54:322026-06A219564-005TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22025-09-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A219564-001AB21a50c72e98297…
2026-08-01 22:54:322026-06A219564-002AB21a50c72e98297…
2026-08-01 22:54:322026-06A219564-003AB21a50c72e98297…
2026-08-01 22:54:322026-06A219564-004AB21a50c72e98297…
2026-08-01 22:54:322026-06A219564-005AB21a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEAjanta Pharma USA Inc.813f5fe2-df82-479c-8014-d503ff5df52b2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219564
application number: ANDA219564
ndc (product): 27241-297

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE50 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
813f5fe2-df82-479c-8014-d503ff5df52bAvailable 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
27241-297-30Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812427topiramate 100 MG Sprinkle 24HR Extended Release Oral CapsulePSN813f5fe2-df82-479c-8014-d503ff5df52b5
1494769topiramate 150 MG Sprinkle 24HR Extended Release Oral CapsulePSN813f5fe2-df82-479c-8014-d503ff5df52b5
1812419topiramate 200 MG Sprinkle 24HR Extended Release Oral CapsulePSN813f5fe2-df82-479c-8014-d503ff5df52b5
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsulePSN813f5fe2-df82-479c-8014-d503ff5df52b5
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsulePSN813f5fe2-df82-479c-8014-d503ff5df52b5
1812427Sprinkle 24 HR topiramate 100 MG Extended Release Oral CapsuleSCD813f5fe2-df82-479c-8014-d503ff5df52b5
1494769Sprinkle 24 HR topiramate 150 MG Extended Release Oral CapsuleSCD813f5fe2-df82-479c-8014-d503ff5df52b5
1812419Sprinkle 24 HR topiramate 200 MG Extended Release Oral CapsuleSCD813f5fe2-df82-479c-8014-d503ff5df52b5
1812421Sprinkle 24 HR topiramate 25 MG Extended Release Oral CapsuleSCD813f5fe2-df82-479c-8014-d503ff5df52b5
1812425Sprinkle 24 HR topiramate 50 MG Extended Release Oral CapsuleSCD813f5fe2-df82-479c-8014-d503ff5df52b5
1812427topiramate 100 MG Sprinkle 24 HR Extended Release Oral CapsuleSY813f5fe2-df82-479c-8014-d503ff5df52b5
1494769topiramate 150 MG Sprinkle 24 HR Extended Release Oral CapsuleSY813f5fe2-df82-479c-8014-d503ff5df52b5
1812419topiramate 200 MG Sprinkle 24 HR Extended Release Oral CapsuleSY813f5fe2-df82-479c-8014-d503ff5df52b5
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsuleSY813f5fe2-df82-479c-8014-d503ff5df52b5
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsuleSY813f5fe2-df82-479c-8014-d503ff5df52b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27241-297-302724102973030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-297-30) 2025-09-02NoNoCurrent