16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ERAXIS (anidulafungin) for Injection is supplied in a single-dose vial of sterile, lyophilized, preservative-free, white to off-white powder. ERAXIS (anidulafungin) is available in the following packaging configuration:
| Single-Dose Vial of ERAXIS 50 mg | |
| NDC 0049-0114-28 | One - 50 mg vial |
| Single-Dose Vial of ERAXIS 100 mg | |
| NDC 0049-0116-28 | One - 100 mg vial |
16.2 Storage
ERAXIS vials
ERAXIS (unreconstituted) vials should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F). Do not freeze.
Excursions for 96 hours up to 25°C (77°F) are permitted, and the vial can be returned to storage at 2°C – 8°C (36°F – 46°F).
Reconstituted solution
ERAXIS reconstituted solution can be stored at up to 25°C (77°F) for up to 24 hours [see Dosage and Administration (2.3)].
Infusion Solution
ERAXIS infusion solution can be stored at temperatures up to 25°C (77°F) for up to 48 hours. Do not freeze [see Dosage and Administration (2.4)].