Topiramate

Product NDC: 47335-711
11-digit product format: 473350711
Labeler code: 47335
Product ID: 47335-711_d4bed9ab-a090-49fe-a95e-5a7ce29c78ac
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: 2014-12-15
Substance: TOPIRAMATE
Active strength: 100 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	47335-711	47335-711-13	D	Discontinued by firm		2026-08-03

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090278-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A090278-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A090278-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A090278-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL		2009-03-27

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL		2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL		2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL		2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090278-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090278-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090278-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090278-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090278-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090278-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090278-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090278-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090278-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090278-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090278-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090278-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090278-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090278-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090278-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090278-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090278-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090278-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090278-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090278-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090278-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090278-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090278-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090278-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090278-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090278-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090278-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090278-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090278-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090278-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090278-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090278-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090278-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090278-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090278-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090278-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090278-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090278-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090278-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090278-003	AB	1	`79d66fd596c7…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	e846124d-e9e6-42c7-83f1-5df170d3f70b	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	47ef2964-3a41-4bfd-86fb-d44560b9961f	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	484c132f-3d3d-4218-b22f-82e9b56cc2f4	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	1b847969-2124-4350-94b0-ef5ba707673b	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	021005ab-6a00-40d8-9aee-20c91613b4d5	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	Sun Pharmaceutical Industries, Inc.	3c909a53-ae66-4b28-a741-b60bb25a69cf	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278 ndc (product): 47335-711
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	61390be3-7553-4cb5-b5da-7571ed7d4b17	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	ffaacad8-4594-45a8-b292-02a84cd0c35b	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	9ddb8451-a455-87ec-e053-2995a90a5e5e	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	Proficient Rx LP	8bd03bb2-3b9b-4707-a9a4-5618ddc3832f	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
TOPIRAMATE	TOPIRAMATE	Proficient Rx LP	a30c583a-4b0a-43a6-ae76-19b1a5e916ca	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	Proficient Rx LP	e382a731-ef73-4990-bc74-ffc3a91ff3ba	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	Proficient Rx LP	7d6752ce-7a56-4b04-ab15-cbd40aa5cc94	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278
Topiramate	TOPIRAMATE	Sun Pharmaceutical Industries, Inc.	2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef	2018-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090278 application number: ANDA090278

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPIRAMATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0H73WJJ391	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
151226	Internal RxNorm lookup
199888	Internal RxNorm lookup
199889	Internal RxNorm lookup
199890	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3c909a53-ae66-4b28-a741-b60bb25a69cf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedc	Product name	4	20260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077	Product name	2	20250623
cb966f54-bbf0-40fb-b581-80c6648d510c	Product name	4	20250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193	Product name	4	20250305
3d272a3f-17c0-421d-bc43-3cbdb719258d	Product name	1	20250303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47335-711-08	Topiramate	100 in 1 BOTTLE	TABLET, FILM COATED	100	22
47335-711-13	Topiramate	500 in 1 BOTTLE	TABLET, FILM COATED	500	22
47335-711-18	Topiramate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	22
47335-711-83	Topiramate	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
47335-711-86	Topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	22
47335-711-88	Topiramate	100 in 1 BOTTLE	TABLET, FILM COATED	100	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-711-13	EA - Each	47335-711	71ed8043-c297-4803-b735-4b90d65fbb43	1	2015-03-03
47335-711-86	EA - Each	47335-711	0418c5d4-1b21-44aa-aa7b-c46aca322ba7	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-711	TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	20	Current NDC, Legacy NDC, 6 package rows	20231229_3c909a53-ae66-4b28-a741-b60bb25a69cf.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0H73WJJ391	TOPIRAMATE	97240-79-4	TOPIRAMATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199889	topiramate 100 MG Oral Tablet	PSN	e846124d-e9e6-42c7-83f1-5df170d3f70b	25
199889	topiramate 100 MG Oral Tablet	SCD	e846124d-e9e6-42c7-83f1-5df170d3f70b	25
199889	topiramate 100 MG Oral Tablet	PSN	484c132f-3d3d-4218-b22f-82e9b56cc2f4	18
199889	topiramate 100 MG Oral Tablet	SCD	484c132f-3d3d-4218-b22f-82e9b56cc2f4	18
199889	topiramate 100 MG Oral Tablet	PSN	7d6752ce-7a56-4b04-ab15-cbd40aa5cc94	3
199889	topiramate 100 MG Oral Tablet	PSN	907c4230-257e-45fd-e053-2995a90a9a66	3
199889	topiramate 100 MG Oral Tablet	SCD	7d6752ce-7a56-4b04-ab15-cbd40aa5cc94	3
199889	topiramate 100 MG Oral Tablet	SCD	907c4230-257e-45fd-e053-2995a90a9a66	3
199889	topiramate 100 MG Oral Tablet	PSN	907a9929-4e0f-2f14-e053-2a95a90a244f	2
199889	topiramate 100 MG Oral Tablet	SCD	907a9929-4e0f-2f14-e053-2a95a90a244f	2
199889	topiramate 100 MG Oral Tablet	PSN	35bd4587-6e8a-13a1-e054-00144ff88e88	1
199889	topiramate 100 MG Oral Tablet	SCD	35bd4587-6e8a-13a1-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-711-08	47335071108	100 TABLET, FILM COATED in 1 BOTTLE (47335-711-08)	2014-12-15	0000-00-00	No	No	Current
47335-711-13	47335071113	500 TABLET, FILM COATED in 1 BOTTLE (47335-711-13)	2014-12-15	0000-00-00	No	No	Current
47335-711-18	47335071118	1000 TABLET, FILM COATED in 1 BOTTLE (47335-711-18)	2014-12-15	0000-00-00	No	No	Current
47335-711-83	47335071183	30 TABLET, FILM COATED in 1 BOTTLE (47335-711-83)	2014-12-15	0000-00-00	No	No	Current
47335-711-86	47335071186	60 TABLET, FILM COATED in 1 BOTTLE (47335-711-86)	2014-12-15	0000-00-00	No	No	Current
47335-711-88	47335071188	100 TABLET, FILM COATED in 1 BOTTLE (47335-711-88)	2014-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate	PD-Rx Pharmaceuticals, Inc.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	26
Topiramate	Bryant Ranch Prepack	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	19
Topiramate	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	24
TOPIRAMATE	Direct_Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	3
TOPIRAMATE	Direct_Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
Topiramate	REMEDYREPACK INC.	2022-03-09	HUMAN PRESCRIPTION DRUG LABEL	6
Topiramate	A-S Medication Solutions	2021-03-01	Human Prescription Drug Label	5
Topiramate	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	2
Topiramate	Quality Care Products, LLC	2020-10-08	Human Prescription Drug Label	3
Topiramate	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Topiramate	Preferred Pharmaceuticals Inc.	2019-04-08	HUMAN PRESCRIPTION DRUG LABEL	3
Topiramate	NuCare Pharmaceuticals, Inc.	2017-02-21	HUMAN PRESCRIPTION DRUG LABEL	1
Topiramate	Apotheca Inc.	2016-06-20	HUMAN PRESCRIPTION DRUG LABEL	1