Rezenopy (naloxone hcl) NDC 83245-003

NDC codes

FDA NDC Directory

Product NDC (as listed)83245-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83245-0003Add 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
83245-003-01	83245000301	2 BLISTER PACK in 1 CARTON (83245-003-01) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .11 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 29, 2026

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): Rezenopy
Generic name (nonproprietary): naloxone hcl
Active ingredients: Naloxone hydrochloride — 10 mg/.11mL
Dosage form: Spray
Route: Nasal
Labeler: Scienture LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215487
Marketing start: Jan 29, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 83245-003_6585ecb7-d8c3-4f64-b485-8d0f0c61d376SPL ID 6585ecb7-d8c3-4f64-b485-8d0f0c61d376SPL set ID 5bb502aa-014f-4a36-8972-42a9439168feRxCUI 2704891, 2704898UNII F850569PQRUPC 0383245003013
Pharmacologic class: Opioid Antagonist

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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N483245000301 followed by a unit qualifier and the quantity

Package 83245-0003-01. 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 Mar 3, 2026.

Indications (excerpt from the label)

REZENOPY nasal spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. REZENOPY nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. REZENOPY nasal spray is not a substitute for emergency medical care. REZENOPY nasal spray is an opioid antagonist for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. ( 1 ) REZENOPY nasal spray is intended for immediate administration as emergency therap…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)