NDC 73309-075-01 - 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: 73309-075-01
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
Label	Manufacturer	Effective date	Type
Leflunomide - BLUEBAY SHANDONG CO.,LTD	BLUEBAY SHANDONG CO.,LTD	2020-04-14	BULK INGREDIENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73309-075-01	Leflunomide	100 g in 1 JAR	POWDER	100	4
73309-075-02	Leflunomide	500 g in 1 JAR	POWDER	500	4
73309-075-03	Leflunomide	50 g in 1 JAR	POWDER	50	4
73309-075-04	Leflunomide	1000 g in 1 JAR	POWDER	1000	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73309-075	LEFLUNOMIDE POWDER [BLUEBAY SHANDONG CO.,LTD]	4	4 package rows	20200415_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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	af4079af-c127-476e-a2b3-53b438dc9da4	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: G162GK9U4W
leflunomide	LEFLUNOMIDE	Zydus Pharmaceuticals (USA) Inc.	b9af9870-014f-4c4e-8738-bb04b30b3e85	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: G162GK9U4W
leflunomide	LEFLUNOMIDE	Zydus Lifesciences Limited	c66cacd1-93f7-483a-a2fc-aad53d5342b0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: G162GK9U4W
Leflunomide	LEFLUNOMIDE	Aurobindo Pharma Limited	c358276a-610e-46da-b81a-95c837af205d	2024-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: G162GK9U4W
Leflunomide	LEFLUNOMIDE	Alembic Pharmaceuticals Limited	f6a4107e-b393-45ed-8e5a-70af5bd53826	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: G162GK9U4W

Reported adverse events (FAERS/openFDA)#

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