What is NDC 0469-6501?

0469-6501 is the product NDC for Lexiscan (regadenoson), Regadenoson .08 mg/mL injection, solution, listed with the FDA by Astellas Pharma US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Astellas Pharma US, Inc., NDC labeler code 0469. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lexiscan?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lexiscan NDC 0469-6501 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0469-6501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00469-6501Add 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 NDC	11-digit (billing)	Package	Copy
0469-6501-89	0046965018900469650189	5 mL in 1 SYRINGE, PLASTIC (0469-6501-89)Marketed from Apr 10, 2008

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): Lexiscan
Generic name (nonproprietary): regadenoson
Active ingredients: Regadenoson — .08 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Astellas Pharma US, Inc.NDC labeler code 0469
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022161
Marketing start: Apr 10, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Adenosine Receptor Agonists (Mechanism)
Identifiers: Product ID 0469-6501_8fb5b92b-3654-43ff-98d3-3ac23c9a0b10SPL ID 8fb5b92b-3654-43ff-98d3-3ac23c9a0b10SPL set ID 057289f4-2e18-4c1e-bed4-6c1858e2ef16UNII 2XLN4Y044H
Pharmacologic class: Adenosine Receptor Agonist

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

N400469650189 followed by a unit qualifier and the quantity

Package 00469-6501-89. 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 Dec 21, 2018.

Indications (excerpt from the label)

LEXISCAN ® (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. LEXISCAN ® 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 0469-6501

What is NDC 0469-6501?: 0469-6501 is the product NDC for Lexiscan (regadenoson), Regadenoson .08 mg/mL injection, solution, listed with the FDA by Astellas Pharma US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lexiscan (Regadenoson).
What is the active ingredient?: Regadenoson.
Who is the labeler?: Astellas Pharma US, Inc., NDC labeler code 0469. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lexiscan?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 022161

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

FDA NDC Directory listings under NDA 022161
Product	Strength	Form · route	Labeler	Product NDC
Lexiscan(R) (Regadenoson)	Regadenoson .08 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1448

Lexiscan (Regadenoson) NDC 0469-6501