Prescription drug · ANDA
Alprostadil NDC 71288-206
Alprostadil 500 ug/mL · Injection, Solution, Concentrate · Intravascular · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-206-02 | 71288020602 | 10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01)Marketed from Sep 15, 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)
- Alprostadil
- Generic name (nonproprietary)
- alprostadil
- Active ingredients
- Alprostadil — 500 ug/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravascular
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075196
- Marketing start
- Listing expires
- Other FDA classes
- Genitourinary Arterial Vasodilation (Physiologic effect)Prostaglandin Receptor Agonists (Mechanism)Prostaglandins (Chemical structure)Venous Vasodilation (Physiologic effect)
- Identifiers
- Product ID 71288-206_7e1975e8-b348-400d-a3aa-9a3ac1cba3b0SPL ID 7e1975e8-b348-400d-a3aa-9a3ac1cba3b0SPL set ID 35d229e1-6947-435c-bf54-bfa09cca7e53RxCUI 237212UNII F5TD010360
- Pharmacologic class
- Prostaglandin Analog; Prostaglandin E1 Agonist
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.
- NDC on a medical claim
N471288020602followed by a unit qualifier and the quantityPackage 71288-0206-02. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Alprostadil injection, USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO 2 values; …
Excerpt only. Read the full label for complete information.