Benznidazole

Product NDC: 0642-7463
11-digit product format: 006427463
Labeler code: 0642
Product ID: 0642-7463_3eddc863-2c5b-6505-e063-6394a90a2423
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benznidazole
Dosage form: TABLET
Route: ORAL
Labeler: Exeltis USA, Inc.
Application: NDA209570
Marketing category: NDA
Marketing start: 2018-03-30
Substance: BENZNIDAZOLE
Active strength: 12.5 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209570-001	BENZNIDAZOLE	BENZNIDAZOLE	12.5MG	TABLET / ORAL		RLD	2017-08-29
N209570-002	BENZNIDAZOLE	BENZNIDAZOLE	100MG	TABLET / ORAL		RLD, RS	2017-08-29

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`782e0a99824c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209570-001	ODE-154	2024-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209570-002	ODE-154	2024-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209570-001	ODE-154	2024-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209570-002	ODE-154	2024-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209570-001	ODE-154	2024-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209570-002	ODE-154	2024-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209570-001	ODE-154	2024-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209570-002	ODE-154	2024-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209570-001	ODE-154	2024-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209570-002	ODE-154	2024-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209570-001	ODE-154	2024-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209570-002	ODE-154	2024-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209570-001	ODE-154	2024-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209570-002	ODE-154	2024-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209570-001	ODE-154	2024-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209570-002	ODE-154	2024-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209570-001	ODE-154	2024-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209570-002	ODE-154	2024-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-001	NCE	2022-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-001	ODE-154	2024-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-002	NCE	2022-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-002	ODE-154	2024-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209570-001	NCE	2022-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209570-001	ODE-154	2024-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209570-002	NCE	2022-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209570-002	ODE-154	2024-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209570-001	NCE	2022-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209570-001	ODE-154	2024-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209570-002	NCE	2022-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209570-002	ODE-154	2024-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209570-001	NCE	2022-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209570-001	ODE-154	2024-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209570-002	NCE	2022-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209570-002	ODE-154	2024-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209570-001	NCE	2022-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209570-001	ODE-154	2024-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209570-002	NCE	2022-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209570-002	ODE-154	2024-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209570-001	NCE	2022-08-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209570-001	ODE-154	2024-08-29	`782e0a99824c…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benznidazole	BENZNIDAZOLE	Exeltis USA, Inc.	8983d6a0-f63f-4f8e-bba4-38223f39e29b	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209570 application number: NDA209570 ndc (product): 0642-7463

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZNIDAZOLE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YC42NRJ1ZD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
430551	Internal RxNorm lookup
1993222	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
8983d6a0-f63f-4f8e-bba4-38223f39e29b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0642-7463-12	2023-11-10	C162847	48780-1	f386c649-b975-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS. BENZNIDAZOLE tablets, for oral use Initial U.S. Approval: 2017
0642-7463-12	2023-07-28	C162847	48780-1	f386c649-b975-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS. BENZNIDAZOLE tablets, for oral use Initial U.S. Approval: 2017
0642-7463-12	2023-02-12	C162847	48780-1	f386c649-b975-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS. BENZNIDAZOLE tablets, for oral use Initial U.S. Approval: 2017
0642-7463-12	2023-01-30	C162847	48780-1	f386c649-b975-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS. BENZNIDAZOLE tablets, for oral use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0642-7463-12	Benznidazole	100 in 1 BOTTLE	TABLET	100		13
0642-7463-12	Benznidazole	1 in 1 CARTON	TABLET	1		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0642-7463-12	EA - Each	0642-7463	8dfa2bc3-cc11-4b1d-b21d-a0805250714b	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0642-7463	BENZNIDAZOLE TABLET [EXELTIS USA, INC.]	12	Current NDC, Legacy NDC, 2 package rows	20250308_8983d6a0-f63f-4f8e-bba4-38223f39e29b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YC42NRJ1ZD	BENZNIDAZOLE	22994-85-0	BENZNIDAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
430551	benznidazole 100 MG Oral Tablet	PSN	8983d6a0-f63f-4f8e-bba4-38223f39e29b	13
1993222	benznidazole 12.5 MG Oral Tablet	PSN	8983d6a0-f63f-4f8e-bba4-38223f39e29b	13
430551	benznidazole 100 MG Oral Tablet	SCD	8983d6a0-f63f-4f8e-bba4-38223f39e29b	13
1993222	benznidazole 12.5 MG Oral Tablet	SCD	8983d6a0-f63f-4f8e-bba4-38223f39e29b	13
430551	benznidazole 100 MG Oral Tablet	SY	8983d6a0-f63f-4f8e-bba4-38223f39e29b	13
1993222	benznidazole 12.5 MG Oral Tablet	SY	8983d6a0-f63f-4f8e-bba4-38223f39e29b	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0642-7463-12	00642746312	1 BOTTLE in 1 CARTON (0642-7463-12) / 100 TABLET in 1 BOTTLE	1 bottle	2018-03-30	0000-00-00	No	No	Current