NDC 0049-0116

ERAXIS

Anidulafungin

ERAXIS is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Anidulafungin.

• Product ID: 0049-0116_3ac66b17-3e99-4e85-bdf3-ee219c10c18d
• NDC: 0049-0116
• Product Type: Human Prescription Drug
• Proprietary Name: ERAXIS
• Generic Name: Anidulafungin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2006-02-17
• Marketing Category: NDA / NDA
• Application Number: NDA021632
• Labeler Name: Roerig
• Substance Name: ANIDULAFUNGIN
• Active Ingredient Strength: 100 mg/30mL
• Pharm Classes: Echinocandin Antifungal [EPC],Lipopeptides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0049-0116-28

30 mL in 1 VIAL, SINGLE-USE (0049-0116-28)

• Marketing Start Date: 2006-02-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0049-0116-28 [00049011628]

ERAXIS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021632
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-02-17

Drug Details

Active Ingredients

Ingredient	Strength
ANIDULAFUNGIN	100 mg/30mL

OpenFDA Data

• SPL SET ID: a88d9010-55fb-4a02-baff-042cd27688ea
• Manufacturer:
  • Roerig
• UNII:
  • 9HLM53094I
• RxNorm Concept Unique ID - RxCUI:
  • 1804748
  • 1804743
  • 1804750
  • 1804746

Pharmacological Class

• Echinocandin Antifungal [EPC]
• Lipopeptides [CS]
• Echinocandin Antifungal [EPC]
• Lipopeptides [CS]

NDC Crossover Matching brand name "ERAXIS" or generic name "Anidulafungin"

NDC	Brand Name	Generic Name
0049-0114	ERAXIS	anidulafungin
0049-0116	ERAXIS	anidulafungin