NDC 68727-200-02 - Antizol

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
68727-200
Requested NDC
68727-200-02
Package NDCs from labels
68727-200-02, 68727-200-01
Effective date
2007-02-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ANTIZOL ® (fomepizole) Injection2007-02-08Human prescription drug label
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68727-200-01Antizol1 in 1 CARTONINJECTION, SOLUTION11
68727-200-02Antizol4 in 1 CARTONINJECTION, SOLUTION41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68727-200ANTIZOL (FOMEPIZOLE) INJECTION, SOLUTION [JAZZ PHARMACEUTICALS, INC.]12 package rows20070216_7C6CA6E4-BE08-4BEA-8553-6B3374991A9E.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68727-200-02ML - Milliliter68727-20099d43002-b872-42d8-8089-e2b7b01e977712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fomepizoleACTIVE INGREDIENT83LCM6L2BYANTIZOL (FOMEPIZOLE) INJECTION, SOLUTION1
FOMEPIZOLEACTIVE MOIETY83LCM6L2BYANTIZOL (FOMEPIZOLE) INJECTION, SOLUTION1

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FomepizoleFOMEPIZOLEZydus Pharmaceuticals USA Inc.256910fe-91f2-48f6-b0b4-55edc52dacd42025-11-20Adverse reactionsExact identifier
rxcui: 310414
FomepizoleFOMEPIZOLENavinta LLC6fed6052-f159-46d6-8be1-31e18a7ba9182024-12-19Adverse reactionsExact identifier
rxcui: 310414
FomepizoleFOMEPIZOLESagent Pharmaceuticals1dea37fd-ec17-416e-b28e-980a87d49e1a2023-10-26Adverse reactionsExact identifier
rxcui: 310414
FomepizoleFOMEPIZOLEGland Pharma Limited7e133194-dacb-446a-a657-2d2430a023732023-07-07Adverse reactionsExact identifier
rxcui: 310414
FomepizoleFOMEPIZOLEMylan Institutional LLC911312e2-3a7c-4c97-88a8-b8d92cd129232021-04-15Adverse reactionsExact identifier
rxcui: 310414
fomepizoleFOMEPIZOLEAmerican Regent, Inc.a31d0148-2729-49de-b666-f24b0dfd24012020-02-11Adverse reactionsExact identifier
rxcui: 310414
fomepizoleFOMEPIZOLEAmerican Regent, Inc.82dc2920-af7f-4e43-9f6d-8877a71884cd2019-12-06Adverse reactionsExact identifier
rxcui: 310414
7C6CA6E4-BE08-4BEA-8553-6B3374991A9E7C6CA6E4-BE08-4BEA-8553-6B3374991A9E2007-02-08Boxed warning, Adverse reactionsExact identifier
spl id: 7C6CA6E4-BE08-4BEA-8553-6B3374991A9E
spl set id: 7C6CA6E4-BE08-4BEA-8553-6B3374991A9E

Reported adverse events (FAERS/openFDA)#

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