FDA.reportPublic FDA data

Topiramate

Product NDC
27241-227
11-digit product format
272410227
Labeler code
27241
Product ID
27241-227_b29a0bc6-2706-4a91-a4cb-d8f9a2dd94a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA215663
Marketing category
ANDA
Marketing start
2023-08-15
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215663-001TOPIRAMATETOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12023-08-15
A215663-002TOPIRAMATETOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12023-08-15
A215663-003TOPIRAMATETOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12023-08-15
A215663-004TOPIRAMATETOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215663-001AB1
A215663-002AB1
A215663-003AB1
A215663-004AB1

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.

Product history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12023-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12023-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12023-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215663-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A215663-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A215663-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A215663-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-08-15d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215663-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215663-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215663-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215663-004AB11011fe1cb6892…
2024-02-18 07:12 UTC2024-02A215663-001AB111c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215663-002AB111c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215663-003AB111c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215663-004AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215663-001AB11ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215663-002AB11ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215663-003AB11ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215663-004AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215663-001AB11a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215663-002AB11a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215663-003AB11a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215663-004AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215663-001AB119b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215663-002AB119b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215663-003AB119b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215663-004AB119b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215663-001AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215663-002AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215663-003AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215663-004AB11a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEAjanta Pharma USA Inc.b94629e3-ae2e-473e-b2f5-06e32ee19aa92026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215663
application number: ANDA215663
ndc (product): 27241-227

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 · 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
b94629e3-ae2e-473e-b2f5-06e32ee19aa9Available 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
27241-227-01Topiramate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1008
27241-227-30Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-227TOPIRAMATE CAPSULE, EXTENDED RELEASE [AJANTA PHARMA USA INC.]5Current NDC, 2 package rows20230823_b94629e3-ae2e-473e-b2f5-06e32ee19aa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSNb94629e3-ae2e-473e-b2f5-06e32ee19aa98
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSNb94629e3-ae2e-473e-b2f5-06e32ee19aa98
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSNb94629e3-ae2e-473e-b2f5-06e32ee19aa98
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSNb94629e3-ae2e-473e-b2f5-06e32ee19aa98
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCDb94629e3-ae2e-473e-b2f5-06e32ee19aa98
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCDb94629e3-ae2e-473e-b2f5-06e32ee19aa98
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCDb94629e3-ae2e-473e-b2f5-06e32ee19aa98
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCDb94629e3-ae2e-473e-b2f5-06e32ee19aa98
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSYb94629e3-ae2e-473e-b2f5-06e32ee19aa98
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSYb94629e3-ae2e-473e-b2f5-06e32ee19aa98
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSYb94629e3-ae2e-473e-b2f5-06e32ee19aa98
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSYb94629e3-ae2e-473e-b2f5-06e32ee19aa98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27241-227-0127241022701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-227-01) 2023-08-15NoNoCurrent
27241-227-302724102273030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-227-30) 2023-08-15NoNoCurrent