Leflunomide

Product NDC: 63629-9728
Requested package NDC: 63629-9728-1
11-digit product format: 636299728
Labeler code: 63629
Product ID: 63629-9728_8dc1df53-82db-4ea2-a0d7-0f6add8b5bda
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Leflunomide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA213652
Marketing category: ANDA
Marketing start: 2021-03-29
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 43.

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
A213652-001	LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET / ORAL	AB		2021-03-29
A213652-002	LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET / ORAL	AB		2021-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213652-001	AB
A213652-002	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 2 · 72 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
2026-09-14 22:38:34	2026-08	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213652-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2021-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213652-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2021-03-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213652-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213652-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213652-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213652-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213652-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213652-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213652-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213652-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213652-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213652-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213652-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213652-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213652-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213652-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213652-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213652-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213652-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213652-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213652-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213652-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213652-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213652-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213652-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213652-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213652-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213652-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213652-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213652-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213652-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213652-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213652-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213652-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213652-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213652-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213652-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213652-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213652-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213652-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213652-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213652-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 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
e85c4eed-794c-409b-aed5-3c857b14b1fb	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
63629-9728-1	Leflunomide	90 in 1 BOTTLE	TABLET, FILM COATED	90		101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-9728	LEFLUNOMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	101	Current NDC, 1 package rows	20241004_e85c4eed-794c-409b-aed5-3c857b14b1fb.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leflunomide	LEFLUNOMIDE	A-S Medication Solutions	0a4f8671-b632-4cc5-8dc9-6b863e62b467	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213652 application number: ANDA213652
Leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	e85c4eed-794c-409b-aed5-3c857b14b1fb	2024-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213652 application number: ANDA213652 ndc (package): 63629-9728-1 ndc (product): 63629-9728 ndc11 (package): 63629972801
Leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	acf3efe4-0d70-4718-9c50-789d69ab215d	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213652 application number: ANDA213652
Leflunomide	LEFLUNOMIDE	Aurobindo Pharma Limited	c358276a-610e-46da-b81a-95c837af205d	2024-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213652 application number: ANDA213652

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	e85c4eed-794c-409b-aed5-3c857b14b1fb	101
205284	leflunomide 10 MG Oral Tablet	SCD	e85c4eed-794c-409b-aed5-3c857b14b1fb	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
63629-9728-1	63629972801	90 TABLET, FILM COATED in 1 BOTTLE (63629-9728-1)	2023-08-11	No	No	Current