Naloxone Hydrochloride NDC 0641-6260

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6260Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6260Add 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
0641-6260-25	00641626025	25 VIAL in 1 CARTON (0641-6260-25) / 1 mL in 1 VIAL (0641-6260-01)Marketed from Mar 1, 2022

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): Naloxone Hydrochloride
Generic name (nonproprietary): nalxone hydrochloride
Active ingredients: Naloxone hydrochloride — .4 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070299
Marketing start: Mar 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 0641-6260_531da15c-9a2c-4121-9aa5-85b079d3908bSPL ID 531da15c-9a2c-4121-9aa5-85b079d3908bSPL set ID 1bef59b9-7d51-4f19-a054-44b8eb6c6398RxCUI 1659929UNII F850569PQR
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 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

N400641626025 followed by a unit qualifier and the quantity

Package 00641-6260-25. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 070299

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

FDA NDC Directory listings under ANDA 070299
Product	Strength	Form · route	Labeler	Product NDC
Naloxone Hydrochloridenalxone hydrochloride	Naloxone hydrochloride .4 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Civica, Inc.	72572-450
Naloxone Hydrochloridenalxone hydrochloride	Naloxone hydrochloride .4 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6132
Naloxone Hydrochloride	Naloxone hydrochloride .4 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	HF Acquisition Co LLC, DBA HealthFirst	51662-1671
Naloxone Hydrochloridenalxone hydrochloride	Naloxone hydrochloride .4 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Medical Purchasing Solutions, LLC	71872-7009

Naloxone Hydrochloride (nalxone hydrochloride) NDC 0641-6260