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NDC 00049-0116-28 ERAXIS 100 mg/30mL Details
ERAXIS 100 mg/30mL
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 Information
| NDC | 00049-0116 |
|---|---|
| Product ID | 0049-0116_fa6cff94-4d7e-4240-b7e1-7fd3e573ed47 |
| Associated GPIs | 11500010002130 |
| GCN Sequence Number | 062989 |
| GCN Sequence Number Description | anidulafungin VIAL 100 MG INTRAVEN |
| HIC3 | W3A |
| HIC3 Description | ANTIFUNGAL ANTIBIOTICS |
| GCN | 98749 |
| HICL Sequence Number | 033502 |
| HICL Sequence Number Description | ANIDULAFUNGIN |
| Brand/Generic | Brand |
| Proprietary Name | ERAXIS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | anidulafungin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/30mL |
| Substance Name | ANIDULAFUNGIN |
| Labeler Name | Roerig |
| Pharmaceutical Class | Echinocandin Antifungal [EPC], Lipopeptides [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021632 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00049-0116-28 (00049011628)
| NDC Package Code | 0049-0116-28 |
|---|---|
| Billing NDC | 00049011628 |
| Package | 30 mL in 1 VIAL, SINGLE-USE (0049-0116-28) |
| Marketing Start Date | 2006-02-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |