Prescription drug · NDA
Eraxis (Anidulafungin) NDC 0049-0114
Anidulafungin 50 mg/15mL · Injection, Powder, Lyophilized, For solution · Intravenous · Roerig
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0049-0114-28 | 00049011428 | 15 mL in 1 VIAL, SINGLE-USE (0049-0114-28)Marketed from Feb 17, 2006 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Eraxis
- Generic name (nonproprietary)
- anidulafungin
- Active ingredients
- Anidulafungin — 50 mg/15mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- RoerigNDC labeler code 0049
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021632
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 0049-0114_f59883f3-edec-4246-a236-790cc492fdb9SPL ID f59883f3-edec-4246-a236-790cc492fdb9SPL set ID a88d9010-55fb-4a02-baff-042cd27688eaRxCUI 1804743, 1804746, 1804748, 1804750UNII 9HLM53094I
- Pharmacologic class
- Echinocandin Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400049011428followed by a unit qualifier and the quantityPackage 00049-0114-28. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) ( 1.1 ) • Esophageal candidiasis in adults ( 1.2 ) Limitations of use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established. ( 1.3 , 5.3 , 8.4 ) • ERAXIS is associated with high relapse rates in esophageal candidiasis…
Excerpt only. Read the full label for complete information.
About NDC 0049-0114
- What is NDC 0049-0114?
- 0049-0114 is the product NDC for Eraxis (anidulafungin), Anidulafungin 50 mg/15mL injection, powder, lyophilized, for solution, listed with the FDA by Roerig. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eraxis (Anidulafungin).
- What is the active ingredient?
- Anidulafungin.
- Who is the labeler?
- Roerig, NDC labeler code 0049. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eraxis?
- 2 other product NDCs are listed under this name. See all Eraxis NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eraxis products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eraxisanidulafungin | Anidulafungin 100 mg/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Roerig | 0049-2242 | 00049-2242-01 |
| Eraxisanidulafungin | Anidulafungin 100 mg/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Roerig | 0049-0116 | 00049-0116-28 |
Other NDCs under NDA 021632
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Eraxisanidulafungin | Anidulafungin 100 mg/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Roerig | 0049-0116 |
| Eraxisanidulafungin | Anidulafungin 100 mg/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Roerig | 0049-2242 |