eraxis

Generic: anidulafungin

Labeler: roerig
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name eraxis
Generic Name anidulafungin
Labeler roerig
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

anidulafungin 100 mg/30mL

Manufacturer
Roerig

Identifiers & Regulatory

Product NDC 0049-2242
Product ID 0049-2242_febc29a8-fd4f-40bc-9335-b4e2233ea606
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021632
Listing Expiration 2026-12-31
Marketing Start 2024-02-20

Pharmacologic Class

Established (EPC)
echinocandin antifungal [epc]
Chemical Structure
lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00492242
Hyphenated Format 0049-2242

Supplemental Identifiers

RxCUI
1804748 1804750
UNII
9HLM53094I
NUI
N0000175507 M0519359

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name eraxis (source: ndc)
Generic Name anidulafungin (source: ndc)
Application Number NDA021632 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/30mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0049-2242-01) / 30 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0049-2242-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0049-2242-01) / 30 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

anidulafungin (100 mg/30mL)

Linked Drug Pages (1)

ERAXIS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "febc29a8-fd4f-40bc-9335-b4e2233ea606", "openfda": {"nui": ["N0000175507", "M0519359"], "unii": ["9HLM53094I"], "rxcui": ["1804748", "1804750"], "spl_set_id": ["d138ab10-1ed9-44be-8d81-49dda1e434ac"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Echinocandin Antifungal [EPC]"], "manufacturer_name": ["Roerig"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0049-2242-01)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0049-2242-01", "marketing_start_date": "20240220"}], "brand_name": "ERAXIS", "product_id": "0049-2242_febc29a8-fd4f-40bc-9335-b4e2233ea606", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "0049-2242", "generic_name": "anidulafungin", "labeler_name": "Roerig", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERAXIS", "active_ingredients": [{"name": "ANIDULAFUNGIN", "strength": "100 mg/30mL"}], "application_number": "NDA021632", "marketing_category": "NDA", "marketing_start_date": "20240220", "listing_expiration_date": "20261231"}