FDA.reportPublic FDA data

fomepizole

Product NDC
0517-0710
11-digit product format
005170710
Labeler code
0517
Product ID
0517-0710_aac796de-58f6-49e5-b959-f95b0c7b8889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fomepizole
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
ANDA078368
Marketing category
ANDA
Marketing start
2020-07-31
Substance
FOMEPIZOLE
Active strength
1 g/mL
Pharmacologic classes
Antidote [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fomepizole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOMEPIZOLE1 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83LCM6L2BY
Rxcui310414

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17cfe3bd-feab-64ba-c922-20d9bc250c81Product name220240809

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0710-01fomepizole1.5 mL in 1 VIALINJECTION, SOLUTION1.54
0517-0710-01fomepizole1 in 1 CARTONINJECTION, SOLUTION14
0517-0710-88fomepizole1 in 1 CARTONINJECTION, SOLUTION14
0517-0710-88fomepizole1.5 mL in 1 VIALINJECTION, SOLUTION1.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0710-01ML - Milliliter0517-0710cc6bdf01-b783-47dc-8e5d-0d436430839512018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0710FOMEPIZOLE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4Current NDC, Legacy NDC, 2 package rows20210126_a31d0148-2729-49de-b666-f24b0dfd2401.zip
0517-0710FOMEPIZOLE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4Current NDC, Legacy NDC, 2 package rows20210126_82dc2920-af7f-4e43-9f6d-8877a71884cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310414fomepizole 1.5 GM in 1.5 ML InjectionPSN82dc2920-af7f-4e43-9f6d-8877a71884cd4
310414fomepizole 1.5 GM in 1.5 ML InjectionPSNa31d0148-2729-49de-b666-f24b0dfd24014
3104141.5 ML fomepizole 1000 MG/ML InjectionSCD82dc2920-af7f-4e43-9f6d-8877a71884cd4
3104141.5 ML fomepizole 1000 MG/ML InjectionSCDa31d0148-2729-49de-b666-f24b0dfd24014
310414fomepizole 1.5 GM per 1.5 ML InjectionSY82dc2920-af7f-4e43-9f6d-8877a71884cd4
310414fomepizole 1.5 GM per 1.5 ML InjectionSYa31d0148-2729-49de-b666-f24b0dfd24014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-0710-01005170710011 VIAL in 1 CARTON (0517-0710-01) / 1.5 mL in 1 VIAL1 vial2018-07-160000-00-00NoNoCurrent
0517-0710-88005170710881 VIAL in 1 CARTON (0517-0710-88) / 1.5 mL in 1 VIAL1 vial2020-07-310000-00-00NoNoCurrent