FDA.reportPublic FDA data

NDC 73309-075-04 - Leflunomide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
73309-075
Requested NDC
73309-075-04
Package NDCs from labels
73309-075-01, 73309-075-02, 73309-075-03, 73309-075-04
Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2020-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leflunomide - BLUEBAY SHANDONG CO.,LTDBLUEBAY SHANDONG CO.,LTD2020-04-14BULK INGREDIENT

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

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 reactionsExact identifier
unii: G162GK9U4W
leflunomideLEFLUNOMIDEBryant Ranch Prepacke76d7767-744f-4e52-956d-e59f7a9248262026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
leflunomideLEFLUNOMIDEBryant Ranch Prepack91712aad-d96c-4ef0-97e7-b31ed18ca6d82026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LEFLUNOMIDELEFLUNOMIDEAvKARE8b365514-c859-ff93-e053-2a95a90ac6982026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LEFLUNOMIDELEFLUNOMIDEAvPAKaf836cd0-da42-772e-e053-2995a90ac1032026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LeflunomideLEFLUNOMIDEChartwell RX, LLC006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc12025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
leflunomideLEFLUNOMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.40dd071a-d07f-452f-bf1a-2a23b9d22ca42025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LeflunomideLEFLUNOMIDELupin Pharmaceuticals, Inc.5d48fded-b43b-461a-8488-ca1da5c41a032025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
leflunomideLEFLUNOMIDEBryant Ranch Prepackfa5f71b3-6a56-4616-baf7-4b761023b2a92025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
leflunomideLEFLUNOMIDEBryant Ranch Prepackd0fb9685-9e54-44e5-b543-1077e1a620c62025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LEFLUNOMIDELEFLUNOMIDEApotex Corp.753453c5-8a7a-878e-3ce7-1d1edce718a92025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LeflunomideLEFLUNOMIDEKVK-Tech, Inc.a48e6ef2-48ad-4fcf-9e67-dbba83ab0b792025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
AravaLEFLUNOMIDEsanofi-aventis U.S. LLC320f63f2-fac3-4aee-aff8-85724e00ef522025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
leflunomideLEFLUNOMIDEA-S Medication Solutionsd6f5c510-9ec2-4e2d-b134-25c35bd23fee2025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LeflunomideLEFLUNOMIDENuCare Pharmaceuticals, Inc.2b5c98d0-de59-85f6-e063-6394a90ab67a2025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
leflunomideLEFLUNOMIDENuCare Pharmaceuticals, Inc.2b5f387e-b52b-ad80-e063-6394a90a56d52025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LeflunomideLEFLUNOMIDEA-S Medication Solutions0a4f8671-b632-4cc5-8dc9-6b863e62b4672025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LeflunomideLEFLUNOMIDEBryant Ranch Prepacke85c4eed-794c-409b-aed5-3c857b14b1fb2024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LeflunomideLEFLUNOMIDEBryant Ranch Prepackacf3efe4-0d70-4718-9c50-789d69ab215d2024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W
LeflunomideLEFLUNOMIDEAlembic Pharmaceuticals Inc.c288d1d3-3fbe-4c34-a28a-923d515809b32024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G162GK9U4W

Reported adverse events (FAERS/openFDA)#

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