leflunomide

Product NDC: 70771-1491
11-digit product format: 707711491
Labeler code: 70771
Product ID: 70771-1491_e96c4125-a2bf-420c-8ffe-6d7ddb7dd645
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leflunomide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA212308
Marketing category: ANDA
Marketing start: 2019-04-26
Substance: LEFLUNOMIDE
Active strength: 10 mg/1
Pharmacologic classes: Antirheumatic Agent [EPC]
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 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
A212308-001	LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET / ORAL	AB		2019-04-24
A212308-002	LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET / ORAL	AB		2019-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212308-001	AB
A212308-002	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	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212308-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212308-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-04-24	`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	A212308-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212308-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212308-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212308-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212308-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212308-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212308-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212308-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212308-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212308-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212308-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212308-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212308-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212308-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212308-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212308-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212308-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212308-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212308-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212308-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212308-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212308-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212308-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212308-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212308-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212308-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212308-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212308-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212308-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212308-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212308-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212308-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212308-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212308-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212308-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212308-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212308-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212308-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212308-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212308-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205284	Internal RxNorm lookup
205285	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
c66cacd1-93f7-483a-a2fc-aad53d5342b0	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	SPL version
70771-1491-1	leflunomide	100 in 1 BOTTLE	TABLET, FILM COATED	100	4
70771-1491-3	leflunomide	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
70771-1491-5	leflunomide	500 in 1 BOTTLE	TABLET, FILM COATED	500	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1491	LEFLUNOMIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	4	Current NDC, Legacy NDC, 3 package rows	20240815_c66cacd1-93f7-483a-a2fc-aad53d5342b0.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
leflunomide	LEFLUNOMIDE	A-S Medication Solutions	d6f5c510-9ec2-4e2d-b134-25c35bd23fee	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212308 application number: ANDA212308
leflunomide	LEFLUNOMIDE	NuCare Pharmaceuticals, Inc.	2b5f387e-b52b-ad80-e063-6394a90a56d5	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212308 application number: ANDA212308
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	af4079af-c127-476e-a2b3-53b438dc9da4	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212308 application number: ANDA212308
leflunomide	LEFLUNOMIDE	Zydus Pharmaceuticals (USA) Inc.	b9af9870-014f-4c4e-8738-bb04b30b3e85	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212308 application number: ANDA212308
leflunomide	LEFLUNOMIDE	Zydus Lifesciences Limited	c66cacd1-93f7-483a-a2fc-aad53d5342b0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212308 application number: ANDA212308 ndc (product): 70771-1491

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	c66cacd1-93f7-483a-a2fc-aad53d5342b0	4
205285	leflunomide 20 MG Oral Tablet	PSN	c66cacd1-93f7-483a-a2fc-aad53d5342b0	4
205284	leflunomide 10 MG Oral Tablet	SCD	c66cacd1-93f7-483a-a2fc-aad53d5342b0	4
205285	leflunomide 20 MG Oral Tablet	SCD	c66cacd1-93f7-483a-a2fc-aad53d5342b0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1491-1	70771149101	100 TABLET, FILM COATED in 1 BOTTLE (70771-1491-1)	2019-04-26	0000-00-00	No	No	Current
70771-1491-3	70771149103	30 TABLET, FILM COATED in 1 BOTTLE (70771-1491-3)	2019-04-26	0000-00-00	No	No	Current
70771-1491-5	70771149105	500 TABLET, FILM COATED in 1 BOTTLE (70771-1491-5)	2019-04-26	0000-00-00	No	No	Current