Topiramate

Product NDC
62756-712
11-digit product format
627560712
Labeler code
62756
Product ID
62756-712_b8c52970-05b0-43ea-9122-566998bf4524
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090278
Marketing category
ANDA
Marketing start
2009-03-27
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
2026-12-31
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
A090278-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A090278-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A090278-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A090278-004TOPIRAMATETOPIRAMATE200MGTABLET / ORAL2009-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090278-001AB
A090278-002AB
A090278-003AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-004TOPIRAMATE200MGTABLET / ORAL2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-004TOPIRAMATE200MGTABLET / ORAL2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-004TOPIRAMATE200MGTABLET / ORAL2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090278-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090278-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090278-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-003AB179d66fd596c7…

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2026-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d9513e0-2fb8-46c9-bbd6-b03efd31c3efAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-712-13EA - Each62756-712ebc09b79-3aae-4da5-83ad-8684852b60eb12013-02-13
62756-712-86EA - Each62756-71241a53b44-186f-46a4-85c6-e1b46d807b5c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]3
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-712TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC20181101_2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e846124d-e9e6-42c7-83f1-5df170d3f70b2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack47ef2964-3a41-4bfd-86fb-d44560b9961f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack484c132f-3d3d-4218-b22f-82e9b56cc2f42026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.1b847969-2124-4350-94b0-ef5ba707673b2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.021005ab-6a00-40d8-9aee-20c91613b4d52026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.3c909a53-ae66-4b28-a741-b60bb25a69cf2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack61390be3-7553-4cb5-b5da-7571ed7d4b172024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepackffaacad8-4594-45a8-b292-02a84cd0c35b2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATENuCare Pharmaceuticals,Inc.9ddb8451-a455-87ec-e053-2995a90a5e5e2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LP8bd03bb2-3b9b-4707-a9a4-5618ddc3832f2023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TOPIRAMATETOPIRAMATEProficient Rx LPa30c583a-4b0a-43a6-ae76-19b1a5e916ca2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LPe382a731-ef73-4990-bc74-ffc3a91ff3ba2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LP7d6752ce-7a56-4b04-ab15-cbd40aa5cc942019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef2018-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
ndc (product): 62756-712

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199890topiramate 200 MG Oral TabletPSN96e74365-c240-4d31-afa8-80e14a1b56971001
199890topiramate 200 MG Oral TabletSCD96e74365-c240-4d31-afa8-80e14a1b56971001
199890topiramate 200 MG Oral TabletPSN2082548c-371c-4c98-98a6-effe0a9bd2a46
151226topiramate 50 MG Oral TabletPSN2082548c-371c-4c98-98a6-effe0a9bd2a46
199890topiramate 200 MG Oral TabletSCD2082548c-371c-4c98-98a6-effe0a9bd2a46
151226topiramate 50 MG Oral TabletSCD2082548c-371c-4c98-98a6-effe0a9bd2a46
199890topiramate 200 MG Oral TabletPSN5f03d5e8-8f65-42cd-bbef-707def83905c4
199890topiramate 200 MG Oral TabletSCD5f03d5e8-8f65-42cd-bbef-707def83905c4
199889topiramate 100 MG Oral TabletPSN011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
199890topiramate 200 MG Oral TabletPSN011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
199888topiramate 25 MG Oral TabletPSN011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
151226topiramate 50 MG Oral TabletPSN011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
199889topiramate 100 MG Oral TabletSCD011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
199890topiramate 200 MG Oral TabletSCD011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
199888topiramate 25 MG Oral TabletSCD011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
151226topiramate 50 MG Oral TabletSCD011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
199890topiramate 200 MG Oral TabletPSN566542fc-6ec1-40e4-b8b1-771eb84b179e2
199890topiramate 200 MG Oral TabletSCD566542fc-6ec1-40e4-b8b1-771eb84b179e2
199889topiramate 100 MG Oral TabletPSN56145d1a-1c0c-4c39-951e-45b9f324abcb1
199890topiramate 200 MG Oral TabletPSN56145d1a-1c0c-4c39-951e-45b9f324abcb1
199888topiramate 25 MG Oral TabletPSN56145d1a-1c0c-4c39-951e-45b9f324abcb1
151226topiramate 50 MG Oral TabletPSN56145d1a-1c0c-4c39-951e-45b9f324abcb1
199889topiramate 100 MG Oral TabletSCD56145d1a-1c0c-4c39-951e-45b9f324abcb1
199890topiramate 200 MG Oral TabletSCD56145d1a-1c0c-4c39-951e-45b9f324abcb1
199888topiramate 25 MG Oral TabletSCD56145d1a-1c0c-4c39-951e-45b9f324abcb1
151226topiramate 50 MG Oral TabletSCD56145d1a-1c0c-4c39-951e-45b9f324abcb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-712-0862756071208100 TABLET, FILM COATED in 1 BOTTLE (62756-712-08) 2009-03-270000-00-00NoNoCurrent
62756-712-1362756071213500 TABLET, FILM COATED in 1 BOTTLE (62756-712-13) 2009-03-270000-00-00NoNoCurrent
62756-712-18627560712181000 TABLET, FILM COATED in 1 BOTTLE (62756-712-18) 2009-03-270000-00-00NoNoCurrent
62756-712-836275607128330 TABLET, FILM COATED in 1 BOTTLE (62756-712-83) 2009-03-270000-00-00NoNoCurrent
62756-712-866275607128660 TABLET, FILM COATED in 1 BOTTLE (62756-712-86) 2009-03-270000-00-00NoNoCurrent
62756-712-8862756071288100 TABLET, FILM COATED in 1 BOTTLE (62756-712-88) 2009-03-270000-00-00NoNoCurrent