leflunomide

Product NDC: 23155-043
11-digit product format: 231550043
Labeler code: 23155
Product ID: 23155-043_bb1ee142-184a-4202-9513-e2036758fa6e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leflunomide
Dosage form: TABLET
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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: 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
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: 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
40dd071a-d07f-452f-bf1a-2a23b9d22ca4	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
23155-043-03	leflunomide	30 in 1 BOTTLE	TABLET	30		14
23155-043-05	leflunomide	500 in 1 BOTTLE	TABLET	500		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-043-03	EA - Each	23155-043	1851403c-9ebe-4668-b392-b4516754574d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEFLUNOMIDE	ACTIVE INGREDIENT	G162GK9U4W	LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC]	6
LEFLUNOMIDE	ACTIVE MOIETY	G162GK9U4W	LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-043	LEFLUNOMIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	12	Current NDC, Legacy NDC, 2 package rows	20220430_40dd071a-d07f-452f-bf1a-2a23b9d22ca4.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
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 ndc (product): 23155-043
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
205284	leflunomide 10 MG Oral Tablet	PSN	d0fb9685-9e54-44e5-b543-1077e1a620c6	100
205284	leflunomide 10 MG Oral Tablet	SCD	d0fb9685-9e54-44e5-b543-1077e1a620c6	100
205284	leflunomide 10 MG Oral Tablet	PSN	40dd071a-d07f-452f-bf1a-2a23b9d22ca4	14
205285	leflunomide 20 MG Oral Tablet	PSN	40dd071a-d07f-452f-bf1a-2a23b9d22ca4	14
205284	leflunomide 10 MG Oral Tablet	SCD	40dd071a-d07f-452f-bf1a-2a23b9d22ca4	14
205285	leflunomide 20 MG Oral Tablet	SCD	40dd071a-d07f-452f-bf1a-2a23b9d22ca4	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-043-03	23155004303	30 TABLET in 1 BOTTLE (23155-043-03)	30 tablet	2009-10-29	0000-00-00	No	No	Current
23155-043-05	23155004305	500 TABLET in 1 BOTTLE (23155-043-05)	500 tablet	2009-10-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
leflunomide	Bryant Ranch Prepack	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	102
leflunomide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	14
leflunomide	Bryant Ranch Prepack	2025-10-22	HUMAN PRESCRIPTION DRUG LABEL	100