Prescription drug · NDA
Prostin Vr Pediatric (Alprostadil) NDC 0009-0215
Alprostadil 500 ug/mL · Injection, Solution · Intravascular, Intravenous · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-0215-05 | 0000902150500009021505 | 5 AMPULE in 1 PACKAGE (0009-0215-05) / 1 mL in 1 AMPULE (0009-0215-01)Marketed from Oct 3, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Prostin Vr PediatricSuffix: VR PEDIATRIC
- Generic name (nonproprietary)
- alprostadil
- Active ingredients
- Alprostadil — 500 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravascular, Intravenous
- Labeler
- Pharmacia & Upjohn Company LLCNDC labeler code 0009
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018484
- 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 0009-0215_77f50b86-f209-4f15-9dde-1e348635598eSPL ID 77f50b86-f209-4f15-9dde-1e348635598eSPL set ID 930f8c02-46a8-4cff-a484-660468ab23c3RxCUI 105467, 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.
- 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
N400009021505followed by a unit qualifier and the quantityPackage 00009-0215-05. 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 PROSTIN VR PEDIATRIC Sterile Solution 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…
Excerpt only. Read the full label for complete information.
About NDC 0009-0215
- What is NDC 0009-0215?
- 0009-0215 is the product NDC for Prostin Vr Pediatric (alprostadil), Alprostadil 500 ug/mL injection, solution, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prostin Vr Pediatric (Alprostadil).
- What is the active ingredient?
- Alprostadil.
- Who is the labeler?
- Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prostin Vr Pediatric?
- 1 other product NDC are listed under this name. See all Prostin Vr Pediatric NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prostin Vr Pediatric products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Prostin Vr Pediatricalprostadil | Alprostadil 500 ug/mL | Injection, SolutionIntravascular, Intravenous | Pharmacia & Upjohn Company LLC | 0009-3169 | 00009-3169-06 |
Other NDCs under NDA 018484
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 |
|---|---|---|---|---|
| Prostin Vr Pediatricalprostadil | Alprostadil 500 ug/mL | Injection, SolutionIntravascular, Intravenous | Pharmacia & Upjohn Company LLC | 0009-3169 |