leflunomide

Product NDC: 72162-2409
11-digit product format: 721622409
Labeler code: 72162
Product ID: 72162-2409_2a161440-2216-448b-a0e7-b7264f8a5f92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leflunomide
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077086
Marketing category: ANDA
Marketing start: 2009-10-29
Substance: LEFLUNOMIDE
Active strength: 10 mg/1
Pharmacologic classes: Antirheumatic Agent [EPC]
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 42.

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
A077086-001	LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET / ORAL	AB		2005-09-13
A077086-002	LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET / ORAL	AB		2005-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077086-001	AB
A077086-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077086-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077086-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077086-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077086-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077086-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077086-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077086-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077086-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077086-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077086-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077086-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077086-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077086-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077086-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077086-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077086-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077086-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077086-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077086-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077086-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077086-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077086-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077086-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077086-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077086-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077086-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077086-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077086-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077086-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077086-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077086-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077086-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077086-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077086-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077086-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077086-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077086-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077086-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077086-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077086-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEFLUNOMIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G162GK9U4W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205284	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
e76d7767-744f-4e52-956d-e59f7a924826	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
07b45089-afbe-518f-59f0-bf5b3c5b5d4e	Product name	4	20210927

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2409-3	leflunomide	30 in 1 BOTTLE	TABLET	30		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2409-3	EA - Each	72162-2409	0d61f357-3831-4add-9509-6cd64173d00b	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2409	LEFLUNOMIDE TABLET [BRYANT RANCH PREPACK]	101	Current NDC, 1 package rows	20250313_e76d7767-744f-4e52-956d-e59f7a924826.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	e76d7767-744f-4e52-956d-e59f7a924826	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077086 application number: ANDA077086 ndc (product): 72162-2409
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	91712aad-d96c-4ef0-97e7-b31ed18ca6d8	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077086 application number: ANDA077086
Leflunomide	LEFLUNOMIDE	Chartwell RX, LLC	006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc1	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077086 application number: ANDA077086
leflunomide	LEFLUNOMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	40dd071a-d07f-452f-bf1a-2a23b9d22ca4	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077086 application number: ANDA077086
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	fa5f71b3-6a56-4616-baf7-4b761023b2a9	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077086 application number: ANDA077086
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	d0fb9685-9e54-44e5-b543-1077e1a620c6	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077086 application number: ANDA077086

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G162GK9U4W	LEFLUNOMIDE	75706-12-6	LEFLUNOMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205284	leflunomide 10 MG Oral Tablet	PSN	e76d7767-744f-4e52-956d-e59f7a924826	102
205284	leflunomide 10 MG Oral Tablet	SCD	e76d7767-744f-4e52-956d-e59f7a924826	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2409-3	72162240903	30 TABLET in 1 BOTTLE (72162-2409-3)	30 tablet	2009-10-29	No	No	Current