What is NDC 71288-201?

71288-201 is the product NDC for Regadenoson, Regadenoson .08 mg/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Regadenoson NDC 71288-201 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0201Add 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
71288-201-85	7128802018571288020185	1 SYRINGE, PLASTIC in 1 CARTON (71288-201-85) / 5 mL in 1 SYRINGE, PLASTICMarketed from Apr 11, 2022

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: Meitheal Pharmaceuticals Inc.NDC labeler code 71288
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212806
Marketing start: Apr 11, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Adenosine Receptor Agonists (Mechanism)
Identifiers: Product ID 71288-201_347eb6ed-dadc-4127-be90-24f65150fbffSPL ID 347eb6ed-dadc-4127-be90-24f65150fbffSPL set ID a550b451-fb30-4c1c-a60e-6e40fba20c88UNII 2XLN4Y044H
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

N471288020185 followed by a unit qualifier and the quantity

Package 71288-0201-85. 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 Apr 15, 2022.

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 71288-201

What is NDC 71288-201?: 71288-201 is the product NDC for Regadenoson, Regadenoson .08 mg/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals 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?: Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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
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

All 14 Regadenoson NDCs