NDC codes

FDA NDC Directory
Product NDC (as listed)0409-1401Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00409-1401Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0409-1401-010040914010110 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.

How CPT relates to drug billing

NDC on a medical claim

N400409140101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Regadenoson NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RegadenosonRegadenoson .08 mg/mLInjection, SolutionIntravenousApotex Corp.60505-628860505-6288-00
RegadenosonRegadenoson .08 mg/mLInjection, SolutionIntravenousMarlex Pharmaceuticals, Inc.10135-80310135-0803-51
RegadenosonRegadenoson .08 mg/mLInjection, SolutionIntravenousIndies Pharma Jamaica Limited83032-00183032-0001-02
RegadenosonRegadenoson .08 mg/mLInjection, SolutionIntravenousKanchan Healthcare Inc85742-01285742-0012-09
regadenosonRegadenoson .08 mg/mLInjection, SolutionIntravenousBaxter Healthcare Corporation36000-36436000-0364-01
RegadenosonRegadenoson anhydrous .08 mg/mLInjectionIntravenousDr. Reddy's Laboratories Inc.43598-61643598-0616-11
RegadenosonRegadenoson anhydrous .08 mg/mLInjection, SolutionIntravenousInternational Medication Systems, Limited76329-332176329-3321-00
RegadenosonRegadenoson anhydrous .08 mg/mLInjection, SolutionIntravenousHikma Pharmaceuticals USA Inc.0641-625300641-6253-01
RegadenosonRegadenoson .08 mg/mLInjection, SolutionIntravenousAccord Healthcare Inc.16729-47716729-0477-31
RegadenosonRegadenoson .08 mg/mLInjection, SolutionIntravenousApotex Corp.60505-611660505-6116-00

All 14 Regadenoson NDCs

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in