Prescription drug · ANDA
regadenoson NDC 55150-443
Regadenoson .08 mg/mL · Injection · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-443-01 | 55150044301 | 1 SYRINGE in 1 CARTON (55150-443-01) / 5 mL in 1 SYRINGEMarketed from Oct 26, 2022 |
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)
- regadenoson
- Generic name (nonproprietary)
- regadenoson
- Active ingredients
- Regadenoson — .08 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Eugia US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216437
- Marketing start
- Listing expires
- Other FDA classes
- Adenosine Receptor Agonists (Mechanism)
- Identifiers
- Product ID 55150-443_c82d9c48-e9fd-489b-a9f3-7a28f42d0a1eSPL ID c82d9c48-e9fd-489b-a9f3-7a28f42d0a1eSPL set ID b553eb2d-0c3f-444e-ad4c-282328683110UNII 2XLN4Y044H
- Pharmacologic class
- Pharmacologic Cardiac Stress Test 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
N455150044301followed by a unit qualifier and the quantityPackage 55150-0443-01. 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)
Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress ( 1 ).
Excerpt only. Read the full label for complete information.