Topiramate

Product NDC: 47335-710
11-digit product format: 473350710
Labeler code: 47335
Product ID: 47335-710_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: 50 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-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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A090278-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090278-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090278-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090278-004	TOPIRAMATE	200MG	TABLET / ORAL		2009-03-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090278-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090278-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090278-003	AB	1	`a50c72e98297…`

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): 47335-710
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	50 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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47335-710-08	Topiramate	100 in 1 BOTTLE	TABLET, FILM COATED	100	22
47335-710-13	Topiramate	500 in 1 BOTTLE	TABLET, FILM COATED	500	22
47335-710-18	Topiramate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	22
47335-710-83	Topiramate	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
47335-710-86	Topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	22
47335-710-88	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
47335-710-13	EA - Each	47335-710	82c32886-ef4d-4df4-8bd4-34d2236a9692	1	2015-03-03
47335-710-86	EA - Each	47335-710	b3f87f6e-3398-4d0d-ac9d-2798deca99f1	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
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-710	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
151226	topiramate 50 MG Oral Tablet	PSN	ffaacad8-4594-45a8-b292-02a84cd0c35b	105
151226	topiramate 50 MG Oral Tablet	SCD	ffaacad8-4594-45a8-b292-02a84cd0c35b	105
151226	topiramate 50 MG Oral Tablet	PSN	1b847969-2124-4350-94b0-ef5ba707673b	24
151226	topiramate 50 MG Oral Tablet	SCD	1b847969-2124-4350-94b0-ef5ba707673b	24
151226	topiramate 50 MG Oral Tablet	PSN	6f2dcfd9-b4c2-4c06-abe5-8616632e525f	6
151226	topiramate 50 MG Oral Tablet	SCD	6f2dcfd9-b4c2-4c06-abe5-8616632e525f	6
151226	topiramate 50 MG Oral Tablet	PSN	3ac13777-45fb-45c2-84b8-d56aad796140	4
151226	topiramate 50 MG Oral Tablet	SCD	3ac13777-45fb-45c2-84b8-d56aad796140	4
151226	topiramate 50 MG Oral Tablet	PSN	9ddb8451-a455-87ec-e053-2995a90a5e5e	3
151226	topiramate 50 MG Oral Tablet	SCD	9ddb8451-a455-87ec-e053-2995a90a5e5e	3
151226	topiramate 50 MG Oral Tablet	PSN	8bd03bb2-3b9b-4707-a9a4-5618ddc3832f	1
151226	topiramate 50 MG Oral Tablet	SCD	8bd03bb2-3b9b-4707-a9a4-5618ddc3832f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-710-08	47335071008	100 TABLET, FILM COATED in 1 BOTTLE (47335-710-08)	2014-12-15	0000-00-00	No	No	Current
47335-710-13	47335071013	500 TABLET, FILM COATED in 1 BOTTLE (47335-710-13)	2014-12-15	0000-00-00	No	No	Current
47335-710-18	47335071018	1000 TABLET, FILM COATED in 1 BOTTLE (47335-710-18)	2014-12-15	0000-00-00	No	No	Current
47335-710-83	47335071083	30 TABLET, FILM COATED in 1 BOTTLE (47335-710-83)	2014-12-15	0000-00-00	No	No	Current
47335-710-86	47335071086	60 TABLET, FILM COATED in 1 BOTTLE (47335-710-86)	2014-12-15	0000-00-00	No	No	Current
47335-710-88	47335071088	100 TABLET, FILM COATED in 1 BOTTLE (47335-710-88)	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.	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	25
Topiramate	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	24
Topiramate	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	105
Topiramate	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
Topiramate	Proficient Rx LP	2023-07-01	HUMAN PRESCRIPTION DRUG LABEL	1
Topiramate	Quality Care Products, LLC	2022-08-01	Human Prescription Drug Label	5
Topiramate	A-S Medication Solutions	2021-04-16	Human Prescription Drug Label	6
Topiramate	NuCare Pharmaceuticals, Inc.	2017-02-21	HUMAN PRESCRIPTION DRUG LABEL	1
Topiramate	Apotheca Inc.	2016-06-20	HUMAN PRESCRIPTION DRUG LABEL	4