FDA.reportPublic FDA data

ERAXIS

Product NDC
0049-0116
11-digit product format
000490116
Labeler code
0049
Product ID
0049-0116_f59883f3-edec-4246-a236-790cc492fdb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
anidulafungin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Roerig
Application
NDA021632
Marketing category
NDA
Marketing start
2006-02-17
Substance
ANIDULAFUNGIN
Active strength
100 mg/30mL
Pharmacologic classes
Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANIDULAFUNGIN100 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9HLM53094I
Rxcui1804743, 1804746, 1804748, 1804750

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0049-0116-28ERAXIS30 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-0116-28EA - Each0049-0116b1aa1774-2436-48b8-861c-d1542db198ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANIDULAFUNGINACTIVE INGREDIENT9HLM53094IERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]11
ANIDULAFUNGINACTIVE MOIETY9HLM53094IERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]11
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]11
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]11
MANNITOLINACTIVE INGREDIENT3OWL53L36AERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]11
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]11
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-0116ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]23Current NDC, Legacy NDC, 1 package rows20240302_a88d9010-55fb-4a02-baff-042cd27688ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1804748anidulafungin 100 MG InjectionPSNa88d9010-55fb-4a02-baff-042cd27688ea24
1804743anidulafungin 50 MG InjectionPSNa88d9010-55fb-4a02-baff-042cd27688ea24
1804750Eraxis 100 MG InjectionPSNa88d9010-55fb-4a02-baff-042cd27688ea24
1804746Eraxis 50 MG InjectionPSNa88d9010-55fb-4a02-baff-042cd27688ea24
1804750anidulafungin 100 MG Injection [Eraxis]SBDa88d9010-55fb-4a02-baff-042cd27688ea24
1804746anidulafungin 50 MG Injection [Eraxis]SBDa88d9010-55fb-4a02-baff-042cd27688ea24
1804748anidulafungin 100 MG InjectionSCDa88d9010-55fb-4a02-baff-042cd27688ea24
1804743anidulafungin 50 MG InjectionSCDa88d9010-55fb-4a02-baff-042cd27688ea24
1804750Eraxis 100 MG InjectionSYa88d9010-55fb-4a02-baff-042cd27688ea24
1804746Eraxis 50 MG InjectionSYa88d9010-55fb-4a02-baff-042cd27688ea24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-0116-280004901162830 mL in 1 VIAL, SINGLE-USE (0049-0116-28) 30 ml2006-02-170000-00-00NoNoCurrent