Prescription drug · NDA
Aurlumyn (iloprost) NDC 50633-340
Iloprost 100 ug/mL · Injection, Solution · Intravenous · BTG International Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50633-340-01 | 50633034001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50633-340-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 1, 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)
- Aurlumyn
- Generic name (nonproprietary)
- iloprost
- Active ingredients
- Iloprost — 100 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- BTG International Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217933
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins I (Chemical structure)
- Identifiers
- Product ID 50633-340_58f248cb-1255-2580-e063-6294a90a21b5SPL ID 58f248cb-1255-2580-e063-6294a90a21b5SPL set ID 34036fc0-6832-d066-e063-6394a90a18a4RxCUI 2680303, 2680309UNII JED5K35YGL
- Pharmacologic class
- Prostacycline
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
N450633034001followed by a unit qualifier and the quantityPackage 50633-0340-01. 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)
AURLUMYN is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes ( 1.1 ). 1.1 Frostbite AURLUMYN is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.
Excerpt only. Read the full label for complete information.