NDC codes

FDA NDC Directory
Product NDC (as listed)60505-6116Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-6116Add 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
60505-6116-0605056116001 SYRINGE, PLASTIC in 1 CARTON (60505-6116-0) / 5 mL in 1 SYRINGE, PLASTICMarketed from Mar 10, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Apotex Corp.NDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207604
Marketing start
Listing expires
Other FDA classes
Adenosine Receptor Agonists (Mechanism)
Identifiers
Product ID 60505-6116_c0b12ff5-6e89-5b2d-8fb2-50d4fca1ade2SPL ID c0b12ff5-6e89-5b2d-8fb2-50d4fca1ade2
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

N460505611600 followed by a unit qualifier and the quantity

Package 60505-6116-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-6116

What is NDC 60505-6116?
60505-6116 is the product NDC for Regadenoson, Regadenoson .08 mg/mL injection, solution, listed with the FDA by Apotex Corp.. 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?
Apotex Corp., NDC labeler code 60505. 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 anhydrous .08 mg/mLInjection, SolutionIntravenousHospira, Inc.0409-140100409-1401-01

All 14 Regadenoson NDCs

Other NDCs under ANDA 207604

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207604
ProductStrengthForm · routeLabelerProduct NDC
RegadenosonRegadenoson .08 mg/mLInjection, SolutionIntravenousApotex Corp.60505-6288

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