Prescription drug · NDA
Ethyol (Amifostine) NDC 83107-030
Amifostine 500 mg/10mL · Injection · Intravenous · Legacy Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83107-030-02 | 83107003002 | 3 VIAL, SINGLE-DOSE in 1 CARTON (83107-030-02) / 10 mL in 1 VIAL, SINGLE-DOSE (83107-030-01)Marketed from Mar 16, 2026 |
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)
- Ethyol
- Generic name (nonproprietary)
- amifostine
- Active ingredients
- Amifostine — 500 mg/10mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Legacy Pharma USA Inc.NDC labeler code 83107
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020221
- Marketing start
- Listing expires
- Other FDA classes
- Free Radical Scavenging Activity (Mechanism)
- Identifiers
- Product ID 83107-030_4c20479c-d75a-a0c7-e063-6394a90a9e59SPL ID 4c20479c-d75a-a0c7-e063-6394a90a9e59SPL set ID a17563f2-d231-4385-bc94-0217be78b89dRxCUI 308096, 1803018UNII M487QF2F4V
- Pharmacologic class
- Cytoprotective Agent
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
N483107003002followed by a unit qualifier and the quantityPackage 83107-0030-02. 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)
ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ( 1.1 ) – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. ( 1 , 5.1 , 5.2 ) 1.1 Reduction of Cumulative Renal Toxicity with Chemotherapy ETHYOL (amifostine) i…
Excerpt only. Read the full label for complete information.
About NDC 83107-030
- What is NDC 83107-030?
- 83107-030 is the product NDC for Ethyol (amifostine), Amifostine 500 mg/10mL injection, listed with the FDA by Legacy Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ethyol (Amifostine).
- What is the active ingredient?
- Amifostine.
- Who is the labeler?
- Legacy Pharma USA Inc., NDC labeler code 83107. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ethyol?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.