Prescription drug · ANDA
Regadenoson NDC 85742-012
Regadenoson .08 mg/mL · Injection, Solution · Intravenous · Kanchan Healthcare Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85742-012-09 | 8574200120985742001209 | 1 SYRINGE in 1 CARTON (85742-012-09) / 5 mL in 1 SYRINGEMarketed from Aug 22, 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)
- Regadenoson
- Generic name (nonproprietary)
- regadenoson
- Active ingredients
- Regadenoson — .08 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Kanchan Healthcare IncNDC labeler code 85742
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218054
- Marketing start
- Listing expires
- Other FDA classes
- Adenosine Receptor Agonists (Mechanism)
- Identifiers
- Product ID 85742-012_10a89235-f50b-4c94-a52f-c05470e20523SPL ID 10a89235-f50b-4c94-a52f-c05470e20523SPL set ID b183399d-b8dc-4924-90cd-a1c2247742f3UNII 2XLN4Y044HUPC 0385742012093
- 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
N485742001209followed by a unit qualifier and the quantityPackage 85742-0012-09. 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 85742-012
- What is NDC 85742-012?
- 85742-012 is the product NDC for Regadenoson, Regadenoson .08 mg/mL injection, solution, listed with the FDA by Kanchan Healthcare 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.
- Who is the labeler?
- Kanchan Healthcare Inc, NDC labeler code 85742. 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 | 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 |
| Regadenoson | Regadenoson anhydrous .08 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1401 | 00409-1401-01 |
Other NDCs under ANDA 218054
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 |
|---|---|---|---|---|
| Regadenoson | Regadenoson .08 mg/mL | Injection, SolutionIntravenous | Marlex Pharmaceuticals, Inc. | 10135-803 |
| Regadenoson | Regadenoson .08 mg/mL | Injection, SolutionIntravenous | Indies Pharma Jamaica Limited | 83032-001 |