NDC 73309-384-01 - Fomepizole

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: 73309-384
Requested NDC: 73309-384-01
Package NDCs from labels: 73309-384-01
Manufacturer: BLUEBAY SHANDONG CO.,LTD
Effective date: 2022-03-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Fomepizole - BLUEBAY SHANDONG CO.,LTD	BLUEBAY SHANDONG CO.,LTD	2022-03-23	BULK INGREDIENT - ANIMAL DRUG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73309-384-01	Fomepizole	100 g in 1 BOTTLE	LIQUID	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73309-384	FOMEPIZOLE LIQUID [BLUEBAY SHANDONG CO.,LTD]	1	1 package rows	20220324_550cbf5d-3cae-4a57-93ae-2b4e2457a0c8.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fomepizole	FOMEPIZOLE	Zydus Pharmaceuticals USA Inc.	256910fe-91f2-48f6-b0b4-55edc52dacd4	2025-11-20	Adverse reactions	Exact identifier unii: 83LCM6L2BY
Fomepizole	FOMEPIZOLE	Navinta LLC	6fed6052-f159-46d6-8be1-31e18a7ba918	2024-12-19	Adverse reactions	Exact identifier unii: 83LCM6L2BY
Fomepizole	FOMEPIZOLE	Sagent Pharmaceuticals	1dea37fd-ec17-416e-b28e-980a87d49e1a	2023-10-26	Adverse reactions	Exact identifier unii: 83LCM6L2BY
Fomepizole	FOMEPIZOLE	Gland Pharma Limited	7e133194-dacb-446a-a657-2d2430a02373	2023-07-07	Adverse reactions	Exact identifier unii: 83LCM6L2BY
Fomepizole	FOMEPIZOLE	Mylan Institutional LLC	911312e2-3a7c-4c97-88a8-b8d92cd12923	2021-04-15	Adverse reactions	Exact identifier unii: 83LCM6L2BY
fomepizole	FOMEPIZOLE	American Regent, Inc.	a31d0148-2729-49de-b666-f24b0dfd2401	2020-02-11	Adverse reactions	Exact identifier unii: 83LCM6L2BY
fomepizole	FOMEPIZOLE	American Regent, Inc.	82dc2920-af7f-4e43-9f6d-8877a71884cd	2019-12-06	Adverse reactions	Exact identifier unii: 83LCM6L2BY

Reported adverse events (FAERS/openFDA)#

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