FDA.reportPublic FDA data

Leflunomide

Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2020-04-14
Label type
BULK INGREDIENT
Version
4
Source
full-release
Hydrated at
2026-06-01 02:49:35

Label at a glance#

ProductLeflunomide
Active ingredientLeflunomide
Label structure1 sections

Label contents#

Full prescribing information#

Leflunomide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
07b45089-afbe-518f-59f0-bf5b3c5b5d4eProduct name420210927

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73309-075-01Leflunomide100 g in 1 JARPOWDER1004
73309-075-02Leflunomide500 g in 1 JARPOWDER5004
73309-075-03Leflunomide50 g in 1 JARPOWDER504
73309-075-04Leflunomide1000 g in 1 JARPOWDER10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73309-075LEFLUNOMIDE POWDER [BLUEBAY SHANDONG CO.,LTD]44 package rows20200415_d5598b9d-dfdb-462d-a32b-4c52f9b29fe7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73309-07573309-075-01, 73309-075-02, 73309-075-03, 73309-075-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
LeflunomideG162GK9U4WACTIB

Source Document#

Source XML

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LeflunomideLEFLUNOMIDEBurel Pharmaceuticals, LLCfc044417-cd9a-42f6-8a3d-a14e7c2f81a22026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Leflunomide
generic name: LEFLUNOMIDE
leflunomideLEFLUNOMIDEBryant Ranch Prepacke76d7767-744f-4e52-956d-e59f7a9248262026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: leflunomide
generic name: LEFLUNOMIDE
leflunomideLEFLUNOMIDEBryant Ranch Prepack91712aad-d96c-4ef0-97e7-b31ed18ca6d82026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: leflunomide
generic name: LEFLUNOMIDE
LEFLUNOMIDELEFLUNOMIDEAvKARE8b365514-c859-ff93-e053-2a95a90ac6982026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEFLUNOMIDE
generic name: LEFLUNOMIDE
LEFLUNOMIDELEFLUNOMIDEAvPAKaf836cd0-da42-772e-e053-2995a90ac1032026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEFLUNOMIDE
generic name: LEFLUNOMIDE
LeflunomideLEFLUNOMIDEChartwell RX, LLC006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc12025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Leflunomide
generic name: LEFLUNOMIDE
leflunomideLEFLUNOMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.40dd071a-d07f-452f-bf1a-2a23b9d22ca42025-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: leflunomide
generic name: LEFLUNOMIDE
LeflunomideLEFLUNOMIDELupin Pharmaceuticals, Inc.5d48fded-b43b-461a-8488-ca1da5c41a032025-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Leflunomide
generic name: LEFLUNOMIDE
leflunomideLEFLUNOMIDEBryant Ranch Prepackfa5f71b3-6a56-4616-baf7-4b761023b2a92025-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: leflunomide
generic name: LEFLUNOMIDE
leflunomideLEFLUNOMIDEBryant Ranch Prepackd0fb9685-9e54-44e5-b543-1077e1a620c62025-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: leflunomide
generic name: LEFLUNOMIDE
LEFLUNOMIDELEFLUNOMIDEApotex Corp.753453c5-8a7a-878e-3ce7-1d1edce718a92025-09-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEFLUNOMIDE
generic name: LEFLUNOMIDE
LeflunomideLEFLUNOMIDEKVK-Tech, Inc.a48e6ef2-48ad-4fcf-9e67-dbba83ab0b792025-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Leflunomide
generic name: LEFLUNOMIDE
AravaLEFLUNOMIDEsanofi-aventis U.S. LLC320f63f2-fac3-4aee-aff8-85724e00ef522025-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEFLUNOMIDE
leflunomideLEFLUNOMIDEA-S Medication Solutionsd6f5c510-9ec2-4e2d-b134-25c35bd23fee2025-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: leflunomide
generic name: LEFLUNOMIDE
LeflunomideLEFLUNOMIDENuCare Pharmaceuticals, Inc.2b5c98d0-de59-85f6-e063-6394a90ab67a2025-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Leflunomide
generic name: LEFLUNOMIDE
leflunomideLEFLUNOMIDENuCare Pharmaceuticals, Inc.2b5f387e-b52b-ad80-e063-6394a90a56d52025-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: leflunomide
generic name: LEFLUNOMIDE
LeflunomideLEFLUNOMIDEA-S Medication Solutions0a4f8671-b632-4cc5-8dc9-6b863e62b4672025-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Leflunomide
generic name: LEFLUNOMIDE
LeflunomideLEFLUNOMIDEBryant Ranch Prepacke85c4eed-794c-409b-aed5-3c857b14b1fb2024-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Leflunomide
generic name: LEFLUNOMIDE
LeflunomideLEFLUNOMIDEBryant Ranch Prepackacf3efe4-0d70-4718-9c50-789d69ab215d2024-09-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Leflunomide
generic name: LEFLUNOMIDE
LeflunomideLEFLUNOMIDEAlembic Pharmaceuticals Inc.c288d1d3-3fbe-4c34-a28a-923d515809b32024-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Leflunomide
generic name: LEFLUNOMIDE

Reported adverse events (FAERS/openFDA)#

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