What is NDC 0641-6253?

0641-6253 is the product NDC for Regadenoson, Regadenoson anhydrous .08 mg/mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. 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 0641-6253 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6253Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6253Add 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
0641-6253-01	00641625301	1 SYRINGE, PLASTIC in 1 CARTON (0641-6253-01) / 5 mL in 1 SYRINGE, PLASTICMarketed from Apr 3, 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: Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215827
Marketing start: Apr 3, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adenosine Receptor Agonists (Mechanism)
Identifiers: Product ID 0641-6253_6d9e653e-94ea-444c-85cf-f24cbfb74c65SPL ID 6d9e653e-94ea-444c-85cf-f24cbfb74c65SPL set ID 9e48b407-1ce3-461d-b48e-de183802de25UNII 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

N400641625301 followed by a unit qualifier and the quantity

Package 00641-6253-01. 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 Apr 10, 2024.

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 0641-6253

What is NDC 0641-6253?: 0641-6253 is the product NDC for Regadenoson, Regadenoson anhydrous .08 mg/mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. 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	Kanchan Healthcare Inc	85742-012	85742-0012-09
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 .08 mg/mL	Injection, SolutionIntravenous	Apotex Corp.	60505-6116	60505-6116-00
Regadenoson	Regadenoson .08 mg/mL	Injection, SolutionIntravenous	Accord Healthcare Inc.	16729-477	16729-0477-31
Regadenoson	Regadenoson anhydrous .08 mg/mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-1401	00409-1401-01

All 14 Regadenoson NDCs