Leflunomide

Product NDC: 10702-277
11-digit product format: 107020277
Labeler code: 10702
Product ID: 10702-277_3843c448-c1bf-a403-e063-6394a90a3e77
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Leflunomide
Dosage form: TABLET
Route: ORAL
Labeler: KVK-Tech, Inc.
Application: ANDA212453
Marketing category: ANDA
Marketing start: 2020-07-23
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	10702-277		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10702-277	10702-277-03	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A212453-001	LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET / ORAL	AB		2019-06-03
A212453-002	LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET / ORAL	AB		2019-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212453-001	AB
A212453-002	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	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212453-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2019-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212453-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2019-06-03	`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	A212453-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212453-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212453-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212453-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212453-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212453-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212453-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212453-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212453-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212453-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212453-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212453-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212453-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212453-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212453-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212453-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212453-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212453-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212453-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212453-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212453-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212453-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212453-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212453-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212453-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212453-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212453-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212453-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212453-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212453-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212453-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212453-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212453-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212453-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212453-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212453-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212453-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212453-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212453-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212453-002	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
a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10702-277-03	2024-05-01	C162847	48780-1	1030e365-5569-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. Leflunomide Tablets, for oral use Initial U.S. Approval: 1998
10702-277-03	2024-01-30	C162847	48780-1	1030e365-5569-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. Leflunomide Tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10702-277-03	Leflunomide	30 in 1 BOTTLE	TABLET	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10702-277-03	EA - Each	10702-277	e71ae784-f22c-42f5-81cb-a22a2e37f650	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-277	LEFLUNOMIDE TABLET [KVK-TECH, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240502_a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leflunomide	LEFLUNOMIDE	KVK-Tech, Inc.	a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212453 application number: ANDA212453 ndc (product): 10702-277

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	a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79	6
205285	leflunomide 20 MG Oral Tablet	PSN	a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79	6
205284	leflunomide 10 MG Oral Tablet	SCD	a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79	6
205285	leflunomide 20 MG Oral Tablet	SCD	a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10702-277-03	10702027703	30 TABLET in 1 BOTTLE (10702-277-03)	30 tablet	2020-07-23	0000-00-00	No	No	Current