Leflunomide

Product NDC: 68258-2992
11-digit product format: 682582992
Labeler code: 68258
Product ID: 68258-2992_be0d579b-3b66-4227-b532-b0ee186a24ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Leflunomide
Dosage form: TABLET
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA077086
Marketing category: ANDA
Marketing start: 2009-10-29
Marketing end: 0000-00-00
Substance: LEFLUNOMIDE
Active strength: 20 mg/1
Pharmacologic classes: Antirheumatic Agent [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68258-2992		I	Inactivated by FDA		2026-08-11
excluded package	package	68258-2992	68258-2992-3	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-2992-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-2992-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-2992-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-2992-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-2992-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-2992-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-2992-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-2992-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-2992-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-2992-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68258-2992-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68258-2992-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-2992-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-2992-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-2992-3	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-2992-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-2992-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-2992-3	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-2992-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-2992-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-2992-3	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-2992-3	`110d247fa046…`	`a55b01930146…`

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
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 · 82 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	A077086-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077086-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	A077086-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077086-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-2992-3	2019-11-27	C162847	48780-1	9855e2a2-468c-60a7-e053-dbdaa90a05bd	LEFLUNOMIDE TABLETS, USP 10 MG AND 20 MG Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-2992-3	Leflunomide	30 in 1 BOTTLE	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEFLUNOMIDE	ACTIVE INGREDIENT	G162GK9U4W	LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
LEFLUNOMIDE	ACTIVE MOIETY	G162GK9U4W	LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-2992	LEFLUNOMIDE TABLET [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20131017_2fcef74c-2df9-4b16-b2f6-82c25957a680.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
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
205285	leflunomide 20 MG Oral Tablet	PSN	2fcef74c-2df9-4b16-b2f6-82c25957a680	1
205285	leflunomide 20 MG Oral Tablet	SCD	2fcef74c-2df9-4b16-b2f6-82c25957a680	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-2992-3	68258299203	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEFLUNOMIDE TABLETS, USP 10 MG AND 20 MG Rx only	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-10-17	HUMAN PRESCRIPTION DRUG LABEL	1