Prescription drug · ANDA
Regadenoson NDC 0409-1401
Regadenoson anhydrous .08 mg/mL · Injection, Solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-1401-01 | 00409140101 | 10 CARTON in 1 PACKAGE (0409-1401-01) / 1 SYRINGE, PLASTIC in 1 CARTON / 5 mL in 1 SYRINGE, PLASTIC (0409-1401-05)Marketed from Mar 1, 2023 |
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)
- Regadenoson
- Generic name (nonproprietary)
- regadenoson
- Active ingredients
- Regadenoson anhydrous — .08 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214349
- Marketing start
- Listing expires
- Other FDA classes
- Adenosine Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0409-1401_67995dbc-0e79-4b3b-a6f8-eaeb5048ff3dSPL ID 67995dbc-0e79-4b3b-a6f8-eaeb5048ff3dSPL set ID 0e3f080d-b1fb-47ed-8cd3-90a4206fa704UNII 7AXV542LZ4
- 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
N400409140101followed by a unit qualifier and the quantityPackage 00409-1401-01. 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.
About NDC 0409-1401
- What is NDC 0409-1401?
- 0409-1401 is the product NDC for Regadenoson, Regadenoson anhydrous .08 mg/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Regadenoson.
- What is the active ingredient?
- Regadenoson anhydrous.
- Who is the labeler?
- Hospira, Inc., NDC labeler code 0409. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Regadenoson?
- 13 other product NDCs are listed under this name. See all Regadenoson NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Regadenoson products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Regadenoson | Regadenoson .08 mg/mL | Injection, SolutionIntravenous | Apotex Corp. | 60505-6288 | 60505-6288-00 |
| Regadenoson | Regadenoson .08 mg/mL | Injection, SolutionIntravenous | Marlex Pharmaceuticals, Inc. | 10135-803 | 10135-0803-51 |
| Regadenoson | Regadenoson .08 mg/mL | Injection, SolutionIntravenous | Indies Pharma Jamaica Limited | 83032-001 | 83032-0001-02 |
| Regadenoson | Regadenoson .08 mg/mL | Injection, SolutionIntravenous | Kanchan Healthcare Inc | 85742-012 | 85742-0012-09 |
| regadenoson | Regadenoson .08 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 36000-364 | 36000-0364-01 |
| Regadenoson | Regadenoson anhydrous .08 mg/mL | InjectionIntravenous | Dr. Reddy's Laboratories Inc. | 43598-616 | 43598-0616-11 |
| Regadenoson | Regadenoson anhydrous .08 mg/mL | Injection, SolutionIntravenous | International Medication Systems, Limited | 76329-3321 | 76329-3321-00 |
| Regadenoson | Regadenoson anhydrous .08 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6253 | 00641-6253-01 |
| Regadenoson | Regadenoson .08 mg/mL | Injection, SolutionIntravenous | Accord Healthcare Inc. | 16729-477 | 16729-0477-31 |
| Regadenoson | Regadenoson .08 mg/mL | Injection, SolutionIntravenous | Apotex Corp. | 60505-6116 | 60505-6116-00 |