NDC 70710-1478-01 - 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: 70710-1478
Requested NDC: 70710-1478-01
Package NDCs from labels: 70710-1478-1, 70710-1478-01
Manufacturer: Zydus Pharmaceuticals USA Inc.
Effective date: 2025-11-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Fomepizole - Zydus Pharmaceuticals USA Inc.	Zydus Pharmaceuticals USA Inc.	2025-11-20	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70710-1478-1	Fomepizole	1 in 1 CARTON	INJECTION, SOLUTION	1		8
70710-1478-1	Fomepizole	1.5 mL in 1 VIAL	INJECTION, SOLUTION	1.5		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1478	FOMEPIZOLE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20241222_256910fe-91f2-48f6-b0b4-55edc52dacd4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-1478-1	ML - Milliliter	70710-1478	2f589697-1a71-4fcb-b69b-080c17a46a3c	1	2019-01-24

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 application number: ANDA078537 ndc (package): 70710-1478-1 ndc (product): 70710-1478 ndc11 (package): 70710147801 rxcui: 310414 spl id: 62ff03a3-fb25-41d8-9c6c-d1ad61ea3d31 spl set id: 256910fe-91f2-48f6-b0b4-55edc52dacd4 unii: 83LCM6L2BY
Fomepizole	FOMEPIZOLE	Navinta LLC	6fed6052-f159-46d6-8be1-31e18a7ba918	2024-12-19	Adverse reactions	Exact identifier application number: ANDA078537 rxcui: 310414 unii: 83LCM6L2BY
Fomepizole	FOMEPIZOLE	Sagent Pharmaceuticals	1dea37fd-ec17-416e-b28e-980a87d49e1a	2023-10-26	Adverse reactions	Exact identifier rxcui: 310414 unii: 83LCM6L2BY
Fomepizole	FOMEPIZOLE	Gland Pharma Limited	7e133194-dacb-446a-a657-2d2430a02373	2023-07-07	Adverse reactions	Exact identifier rxcui: 310414 unii: 83LCM6L2BY
Fomepizole	FOMEPIZOLE	Mylan Institutional LLC	911312e2-3a7c-4c97-88a8-b8d92cd12923	2021-04-15	Adverse reactions	Exact identifier rxcui: 310414 unii: 83LCM6L2BY
fomepizole	FOMEPIZOLE	American Regent, Inc.	a31d0148-2729-49de-b666-f24b0dfd2401	2020-02-11	Adverse reactions	Exact identifier rxcui: 310414 unii: 83LCM6L2BY
fomepizole	FOMEPIZOLE	American Regent, Inc.	82dc2920-af7f-4e43-9f6d-8877a71884cd	2019-12-06	Adverse reactions	Exact identifier rxcui: 310414 unii: 83LCM6L2BY

Reported adverse events (FAERS/openFDA)#

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