Prescription drug · ANDA
Epoprostenol NDC 67457-587
Epoprostenol .5 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-587-10 | 67457058710 | 1 VIAL in 1 CARTON (67457-587-10) / 10 mL in 1 VIALMarketed from Sep 25, 2024 |
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)
- Epoprostenol
- Generic name (nonproprietary)
- epoprostenol
- Active ingredients
- Epoprostenol — .5 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213913
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins I (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 67457-587_2a163b77-9e01-4516-b19c-f5a12ce48560SPL ID 2a163b77-9e01-4516-b19c-f5a12ce48560SPL set ID 2a163b77-9e01-4516-b19c-f5a12ce48560RxCUI 562501, 562502UNII DCR9Z582X0UPC 0367457587103
- Pharmacologic class
- Prostacycline Vasodilator
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
N467457058710followed by a unit qualifier and the quantityPackage 67457-0587-10. 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)
Epoprostenol for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. Epoprostenol for injection is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with c…
Excerpt only. Read the full label for complete information.
About NDC 67457-587
- What is NDC 67457-587?
- 67457-587 is the product NDC for Epoprostenol, Epoprostenol .5 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Epoprostenol.
- What is the active ingredient?
- Epoprostenol.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Epoprostenol?
- 5 other product NDCs are listed under this name. See all Epoprostenol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Epoprostenol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Epoprostenol | Epoprostenol 1.5 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-642 | 68083-0642-01 |
| Epoprostenol | Epoprostenol .5 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-707 | 68083-0707-01 |
| Epoprostenol | Epoprostenol 1.5 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-588 | 67457-0588-10 |
| epoprostenol | Epoprostenol sodium .5 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sun Pharmaceutical Industries, Inc. | 62756-059 | 62756-0059-40 |
| epoprostenol | Epoprostenol sodium 1.5 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sun Pharmaceutical Industries, Inc. | 62756-060 | 62756-0060-40 |
Other NDCs under ANDA 213913
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 |
|---|---|---|---|---|
| Epoprostenol | Epoprostenol 1.5 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-588 |