Antizol

Product NDC
46129-200
11-digit product format
461290200
Labeler code
46129
Product ID
46129-200_c045b5a8-b220-4f0a-a831-155b29c19454
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fomepizole
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
PALADIN LABORATORIES (USA) INC
Application
NDA020696
Marketing category
NDA
Marketing start
2009-07-31
Marketing end
0000-00-00
Substance
FOMEPIZOLE
Active strength
1 g/mL
Pharmacologic classes
Antidote [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46129-200-012019-10-21C16284748780-1956f9ecf-cef7-621f-e053-dbdaa90a74adc045b5a8-b220-4f0a-a831-155b29c19454
46129-200-022019-10-21C16284748780-1956f9ecf-cef7-621f-e053-dbdaa90a74adc045b5a8-b220-4f0a-a831-155b29c19454

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46129-200-01Antizol1 in 1 PACKAGEINJECTION11
46129-200-01Antizol1.5 mL in 1 VIALINJECTION1.51
46129-200-02Antizol1.5 mL in 1 VIALINJECTION1.51
46129-200-02Antizol4 in 1 PACKAGEINJECTION41

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOMEPIZOLEACTIVE INGREDIENT83LCM6L2BYANTIZOL (FOMEPIZOLE) INJECTION [PALADIN LABORATORIES (USA) INC]1
FOMEPIZOLEACTIVE MOIETY83LCM6L2BYANTIZOL (FOMEPIZOLE) INJECTION [PALADIN LABORATORIES (USA) INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46129-200ANTIZOL (FOMEPIZOLE) INJECTION [PALADIN LABORATORIES (USA) INC]1Legacy NDC, 4 package rows20090813_c045b5a8-b220-4f0a-a831-155b29c19454.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213184ANTIZOL 1.5 GM in 1.5 ML InjectionPSNc045b5a8-b220-4f0a-a831-155b29c194541
310414fomepizole 1.5 GM in 1.5 ML InjectionPSNc045b5a8-b220-4f0a-a831-155b29c194541
2131841.5 ML fomepizole 1000 MG/ML Injection [Antizol]SBDc045b5a8-b220-4f0a-a831-155b29c194541
3104141.5 ML fomepizole 1000 MG/ML InjectionSCDc045b5a8-b220-4f0a-a831-155b29c194541
2131841.5 ML Antizol 1000 MG/ML InjectionSYc045b5a8-b220-4f0a-a831-155b29c194541
213184Antizol 1.5 GM per 1.5 ML InjectionSYc045b5a8-b220-4f0a-a831-155b29c194541
310414fomepizole 1.5 GM per 1.5 ML InjectionSYc045b5a8-b220-4f0a-a831-155b29c194541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
46129-200-01461290200011 in 1 PACKAGEHistorical
46129-200-02461290200021.5 mL in 1 VIAL1.5 mlHistorical