TOPIRAMATE extended-release capsules, for oral use

Manufacturer
Zydus Lifesciences Limited
Effective date
2023-09-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:53:30

Label at a glance#

ProductTopiramate
Active ingredientTOPIRAMATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1656-3

Topiramate extended-release Capsules 25 mg

Rx only

30 Capsules

25 mg label
25 mg label

NDC 70771-1657-3

Topiramate extended-release Capsules 50 mg

Rx only

30 Capsules

50 mg label
50 mg label

NDC 70771-1658-3

Topiramate extended-release Capsules 100 mg

Rx only

30 Capsules

100 mg label
100 mg label

NDC 70771-1659-3

Topiramate extended-release Capsules 150 mg

Rx only

30 Capsules

150 mg label
150 mg label

NDC 70771-1660-3

Topiramate extended-release Capsules 200 mg

Rx only

30 Capsules

200 mg label
200 mg label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1812427topiramate 100 MG Sprinkle 24HR Extended Release Oral CapsulePSN3
1494769topiramate 150 MG Sprinkle 24HR Extended Release Oral CapsulePSN3
1812419topiramate 200 MG Sprinkle 24HR Extended Release Oral CapsulePSN3
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsulePSN3
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsulePSN3
1812427Sprinkle 24 HR topiramate 100 MG Extended Release Oral CapsuleSCD3
1494769Sprinkle 24 HR topiramate 150 MG Extended Release Oral CapsuleSCD3
1812419Sprinkle 24 HR topiramate 200 MG Extended Release Oral CapsuleSCD3
1812421Sprinkle 24 HR topiramate 25 MG Extended Release Oral CapsuleSCD3
1812425Sprinkle 24 HR topiramate 50 MG Extended Release Oral CapsuleSCD3
1812427topiramate 100 MG Sprinkle 24 HR Extended Release Oral CapsuleSY3
1494769topiramate 150 MG Sprinkle 24 HR Extended Release Oral CapsuleSY3
1812419topiramate 200 MG Sprinkle 24 HR Extended Release Oral CapsuleSY3
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsuleSY3
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsuleSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TOPIRAMATE Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1656-3Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
70771-1656-9Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903
70771-1657-3Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
70771-1657-9Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903
70771-1658-3Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
70771-1658-9Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903
70771-1659-3Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
70771-1659-9Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903
70771-1660-3Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
70771-1660-9Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1656TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 2 package rows20230928_57b5d67b-b29b-4c18-a53d-51d5374f3be3.zip
70771-1657TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 2 package rows20230928_57b5d67b-b29b-4c18-a53d-51d5374f3be3.zip
70771-1658TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 2 package rows20230928_57b5d67b-b29b-4c18-a53d-51d5374f3be3.zip
70771-1659TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 2 package rows20230928_57b5d67b-b29b-4c18-a53d-51d5374f3be3.zip
70771-1660TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 2 package rows20230928_57b5d67b-b29b-4c18-a53d-51d5374f3be3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 90 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208949-001TOPIRAMATETOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29
A208949-002TOPIRAMATETOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29
A208949-003TOPIRAMATETOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29
A208949-004TOPIRAMATETOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29
A208949-005TOPIRAMATETOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208949-001AB2
A208949-002AB2
A208949-003AB2
A208949-004AB2
A208949-005AB2

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.

Product history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208949-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29c2088c7a36db…
2026-10-15 13:18:302026-09A208949-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29c2088c7a36db…
2026-10-15 13:18:302026-09A208949-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29c2088c7a36db…
2026-10-15 13:18:302026-09A208949-004TOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29c2088c7a36db…
2026-10-15 13:18:302026-09A208949-005TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29c2088c7a36db…
2026-09-14 22:38:342026-08A208949-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A208949-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A208949-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A208949-004TOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A208949-005TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2984e616aacf4f…
2026-08-18 06:07:402026-07A208949-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A208949-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A208949-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A208949-004TOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A208949-005TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208949-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208949-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208949-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208949-004TOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208949-005TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-004TOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-005TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208949-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208949-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208949-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208949-004TOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208949-005TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-004TOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-005TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-001TOPIRAMATE25MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-002TOPIRAMATE50MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-003TOPIRAMATE100MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-004TOPIRAMATE150MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-005TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB22022-11-29b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A208949-001AB21c2088c7a36db…
2026-10-15 13:18:302026-09A208949-002AB21c2088c7a36db…
2026-10-15 13:18:302026-09A208949-003AB21c2088c7a36db…
2026-10-15 13:18:302026-09A208949-004AB21c2088c7a36db…
2026-10-15 13:18:302026-09A208949-005AB21c2088c7a36db…
2026-09-14 22:38:342026-08A208949-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A208949-002AB2184e616aacf4f…
2026-09-14 22:38:342026-08A208949-003AB2184e616aacf4f…
2026-09-14 22:38:342026-08A208949-004AB2184e616aacf4f…
2026-09-14 22:38:342026-08A208949-005AB2184e616aacf4f…
2026-08-18 06:07:402026-07A208949-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A208949-002AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A208949-003AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A208949-004AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A208949-005AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208949-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208949-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208949-003AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208949-004AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208949-005AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-003AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-004AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208949-005AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208949-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208949-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208949-003AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208949-004AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208949-005AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-003AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-004AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208949-005AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-003AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-004AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208949-005AB21b8a1b40f171c…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEZydus Lifesciences Limited57b5d67b-b29b-4c18-a53d-51d5374f3be32023-09-28Exact identifier
ndc (package): 70771-1660-3
ndc (package): 70771-1659-3
ndc (package): 70771-1658-3
ndc (package): 70771-1658-9
ndc (package): 70771-1657-3
ndc (package): 70771-1659-9
ndc (package): 70771-1656-9
ndc (package): 70771-1657-9
ndc (package): 70771-1660-9
ndc (package): 70771-1656-3
ndc (product): 70771-1659
ndc (product): 70771-1657
ndc (product): 70771-1656
ndc (product): 70771-1658
ndc (product): 70771-1660
ndc11 (package): 70771165609
ndc11 (package): 70771165909
ndc11 (package): 70771165803
ndc11 (package): 70771166009
ndc11 (package): 70771165603
ndc11 (package): 70771165709
ndc11 (package): 70771165903
ndc11 (package): 70771165809
ndc11 (package): 70771166003
ndc11 (package): 70771165703
spl id: 432dc54b-f28b-48c9-b417-2fbae070f41b
spl set id: 57b5d67b-b29b-4c18-a53d-51d5374f3be3

Reported adverse events (FAERS/openFDA)#

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