FDA.reportPublic FDA data

leflunomide 10 MG Oral Tablet

RxCUI
205284
RxNorm name
leflunomide 10 MG Oral Tablet
Display name
leflunomide 10 MG Oral Tablet
Full name
leflunomide 10 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LeflunomideLEFLUNOMIDEBurel Pharmaceuticals, LLCfc044417-cd9a-42f6-8a3d-a14e7c2f81a22026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
leflunomideLEFLUNOMIDEBryant Ranch Prepacke76d7767-744f-4e52-956d-e59f7a9248262026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LEFLUNOMIDELEFLUNOMIDEAvKARE8b365514-c859-ff93-e053-2a95a90ac6982026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LEFLUNOMIDELEFLUNOMIDEAvPAKaf836cd0-da42-772e-e053-2995a90ac1032026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LeflunomideLEFLUNOMIDEChartwell RX, LLC006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc12025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
leflunomideLEFLUNOMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.40dd071a-d07f-452f-bf1a-2a23b9d22ca42025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LeflunomideLEFLUNOMIDELupin Pharmaceuticals, Inc.5d48fded-b43b-461a-8488-ca1da5c41a032025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
leflunomideLEFLUNOMIDEBryant Ranch Prepackd0fb9685-9e54-44e5-b543-1077e1a620c62025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LEFLUNOMIDELEFLUNOMIDEApotex Corp.753453c5-8a7a-878e-3ce7-1d1edce718a92025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LeflunomideLEFLUNOMIDEKVK-Tech, Inc.a48e6ef2-48ad-4fcf-9e67-dbba83ab0b792025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
AravaLEFLUNOMIDEsanofi-aventis U.S. LLC320f63f2-fac3-4aee-aff8-85724e00ef522025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LeflunomideLEFLUNOMIDENuCare Pharmaceuticals, Inc.2b5c98d0-de59-85f6-e063-6394a90ab67a2025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LeflunomideLEFLUNOMIDEBryant Ranch Prepacke85c4eed-794c-409b-aed5-3c857b14b1fb2024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LeflunomideLEFLUNOMIDEAlembic Pharmaceuticals Inc.c288d1d3-3fbe-4c34-a28a-923d515809b32024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
leflunomideLEFLUNOMIDEZydus Pharmaceuticals (USA) Inc.b9af9870-014f-4c4e-8738-bb04b30b3e852024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
leflunomideLEFLUNOMIDEZydus Lifesciences Limitedc66cacd1-93f7-483a-a2fc-aad53d5342b02024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LeflunomideLEFLUNOMIDEAurobindo Pharma Limitedc358276a-610e-46da-b81a-95c837af205d2024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284
LeflunomideLEFLUNOMIDEAlembic Pharmaceuticals Limitedf6a4107e-b393-45ed-8e5a-70af5bd538262023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205284

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 19 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e76d7767-744f-4e52-956d-e59f7a924826leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]2102These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS, USP safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS, USP. LEFLUNOMIDE tablets, USP for oral use Initial U.S. Approval: 199820260317
e85c4eed-794c-409b-aed5-3c857b14b1fbleflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]2101These 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: 199820241002
d0fb9685-9e54-44e5-b543-1077e1a620c6leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]2100These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS, USP safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS, USP. LEFLUNOMIDE tablets, USP for oral use Initial U.S. Approval: 199820251022
320f63f2-fac3-4aee-aff8-85724e00ef52leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]227These highlights do not include all the information needed to use ARAVA safely and effectively. See full prescribing information for ARAVA. ARAVA (leflunomide) tablets, for oral use Initial U.S. Approval: 199820250604
40dd071a-d07f-452f-bf1a-2a23b9d22ca4leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]214These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS, USP safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS, USP. LEFLUNOMIDE tablets, USP for oral use Initial U.S. Approval: 199820251113
753453c5-8a7a-878e-3ce7-1d1edce718a9leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]212These 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: 199820250919
5d48fded-b43b-461a-8488-ca1da5c41a03leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]29These 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: 199820251029
fc044417-cd9a-42f6-8a3d-a14e7c2f81a2leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]28These 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: 199820250201
c288d1d3-3fbe-4c34-a28a-923d515809b3leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]28These 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: 199820240820
a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]26These 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: 199820250623
b9af9870-014f-4c4e-8738-bb04b30b3e85leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]26These 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: 199820240812
8b365514-c859-ff93-e053-2a95a90ac698leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]25LEFLUNOMIDE TABLETS Rx Only These highlights do not include all the information needed to use See full prescribing information for Initial U.S. Approval20260114
af836cd0-da42-772e-e053-2995a90ac103leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]24Leflunomide Tablets, USP Rx Only These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. Initial U.S. Approval: 199820260108
c66cacd1-93f7-483a-a2fc-aad53d5342b0leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]24These 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: 199820240812
c358276a-610e-46da-b81a-95c837af205dleflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]23These 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: 199820240807
f6a4107e-b393-45ed-8e5a-70af5bd53826leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]23These 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: 199820230130
006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc1leflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]22Leflunomide Tablets, USP 10 mg and 20 mg 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: 199820251217
2b5c98d0-de59-85f6-e063-6394a90ab67aleflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]21These 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: 199820250110
14d06124-1eef-4f97-b1f3-18620819ae1aleflunomide 10 MG Oral Tablet [PSN] · leflunomide 10 MG Oral Tablet [SCD]21Leflunomide Tablets 10 mg and 20 mg20090626