FDA.reportPublic FDA data

Topiramate

Product NDC
68382-863
11-digit product format
683820863
Labeler code
68382
Product ID
68382-863_2535bcc8-fac7-4b15-8c6f-fd6675655fd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA207382
Marketing category
ANDA
Marketing start
2024-09-10
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 43.

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
A207382-001TOPIRAMATETOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24
A207382-002TOPIRAMATETOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24
A207382-003TOPIRAMATETOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24
A207382-004TOPIRAMATETOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207382-001AB1
A207382-002AB1
A207382-003AB1
A207382-004AB1

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 4 · 150 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-2484e616aacf4f…
2026-09-14 22:38:342026-08A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-2484e616aacf4f…
2026-09-14 22:38:342026-08A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-2484e616aacf4f…
2026-09-14 22:38:342026-08A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-3084e616aacf4f…
2026-08-18 06:07:402026-07A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207382-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207382-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207382-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB12017-11-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207382-004TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-10-305bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207382-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A207382-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A207382-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A207382-004AB1184e616aacf4f…
2026-08-18 06:07:402026-07A207382-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A207382-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A207382-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A207382-004AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207382-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207382-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207382-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207382-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207382-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207382-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207382-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207382-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207382-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207382-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207382-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207382-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207382-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207382-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207382-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207382-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207382-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207382-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207382-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207382-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207382-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207382-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207382-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207382-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207382-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207382-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207382-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207382-004AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207382-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207382-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207382-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207382-004AB115bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
f72774dd-c7eb-41f9-9837-02baf77cc523Available 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
68382-863-01Topiramate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10010
68382-863-05Topiramate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50010
68382-863-06Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
68382-863-16Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010
68382-863-30Topiramate10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE1010
68382-863-78Topiramate3 in 1 CARTONCAPSULE, EXTENDED RELEASE310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-863-06EA - Each68382-8639d2c073b-abe6-4e7c-b893-0bc35c98764912023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-863TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 6 package rows20250406_f72774dd-c7eb-41f9-9837-02baf77cc523.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.f72774dd-c7eb-41f9-9837-02baf77cc5232026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207382
application number: ANDA207382
ndc (product): 68382-863
TopiramateTOPIRAMATEZydus Lifesciences Limited9a943af0-1c6d-43c2-830a-f303baa161242023-11-08Exact identifier
application applno (ANDA): 207382
application number: ANDA207382

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSNf72774dd-c7eb-41f9-9837-02baf77cc52310
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSNf72774dd-c7eb-41f9-9837-02baf77cc52310
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSNf72774dd-c7eb-41f9-9837-02baf77cc52310
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSNf72774dd-c7eb-41f9-9837-02baf77cc52310
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCDf72774dd-c7eb-41f9-9837-02baf77cc52310
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCDf72774dd-c7eb-41f9-9837-02baf77cc52310
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCDf72774dd-c7eb-41f9-9837-02baf77cc52310
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCDf72774dd-c7eb-41f9-9837-02baf77cc52310
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSYf72774dd-c7eb-41f9-9837-02baf77cc52310
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSYf72774dd-c7eb-41f9-9837-02baf77cc52310
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSYf72774dd-c7eb-41f9-9837-02baf77cc52310
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSYf72774dd-c7eb-41f9-9837-02baf77cc52310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-863-0168382086301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-01) 2024-09-100000-00-00NoNoCurrent
68382-863-0568382086305500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-05) 2024-09-100000-00-00NoNoCurrent
68382-863-066838208630630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-06) 2024-09-100000-00-00NoNoCurrent
68382-863-166838208631690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-16) 2024-09-100000-00-00NoNoCurrent
68382-863-306838208633010 in 1 BLISTER PACKHistorical
68382-863-776838208637710 BLISTER PACK in 1 CARTON (68382-863-77) > 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30) 10 blister pack2018-04-050000-00-00NoNoCurrent
68382-863-78683820863783 BLISTER PACK in 1 CARTON (68382-863-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30) 3 blister pack2024-09-10NoNoCurrent