Prescription drug · NDA
Rezzayo (rezafungin) NDC 70842-240
Rezafungin 200 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Melinta Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70842-240-01 | 70842024001 | 1 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Jun 9, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Rezzayo
- Generic name (nonproprietary)
- rezafungin
- Active ingredients
- Rezafungin — 200 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Melinta Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217417
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 70842-240_32d9ddc4-232f-45f9-ab7d-a34c46cf9b1cSPL ID 32d9ddc4-232f-45f9-ab7d-a34c46cf9b1cSPL set ID 90073508-6dca-4d27-aa5a-ed837737c35bRxCUI 2639160, 2639165UNII G013B5478J
- 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
N470842024001followed by a unit qualifier and the quantityPackage 70842-0240-01. 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)
REZZAYO is an echinocandin antifungal indicated in adults and pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data for REZZAYO. ( 1 , 12.4 , 14 ) Limitations of Use REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. ( 1 ) 1.1 Treatment of Candidemia and Invasive Candidiasis REZZAYO is indicated in adults and pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis [see Microbiology…
Excerpt only. Read the full label for complete information.