ERAXIS
- Product NDC
- 0049-2242
- 11-digit product format
- 000492242
- Labeler code
- 0049
- Product ID
- 0049-2242_febc29a8-fd4f-40bc-9335-b4e2233ea606
- 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
- 2024-02-20
- 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| Ingredient | Strength |
|---|
| ANIDULAFUNGIN | 100 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9HLM53094I |
| Rxcui | 1804748, 1804750 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0049-2242-01 | ERAXIS | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 30 | | 2 |
| 0049-2242-01 | ERAXIS | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0049-2242 | ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] | 2 | Current NDC, 2 package rows | 20240221_d138ab10-1ed9-44be-8d81-49dda1e434ac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0049-2242-01 | 00049224201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0049-2242-01) / 30 mL in 1 VIAL, SINGLE-DOSE | 2024-02-20 | No | No | Historical |