What is NDC 42291-493?

42291-493 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 4 mg/.1mL spray, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Naloxone Hydrochloride?

77 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Naloxone Hydrochloride NDC 42291-493 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-493Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0493Add 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
42291-493-02	42291049302	2 VIAL, SINGLE-DOSE in 1 CARTON (42291-493-02) / .1 mL in 1 VIAL, SINGLE-DOSE (42291-493-01)Marketed from May 1, 2024

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): Naloxone Hydrochloride
Generic name (nonproprietary): naloxone hydrochloride
Active ingredients: Naloxone hydrochloride — 4 mg/.1mL
Dosage form: Spray
Route: Nasal
Labeler: AvKARENDC labeler code 42291
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217992
Marketing start: May 1, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 42291-493_485f83f8-8404-eae8-e063-6294a90a3c33SPL ID 485f83f8-8404-eae8-e063-6294a90a3c33SPL set ID 1766a7f1-d301-945f-e063-6294a90ac6f4RxCUI 1725059UNII 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 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

N442291049302 followed by a unit qualifier and the quantity

Package 42291-0493-02. 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 Jan 14, 2026.

Indications (excerpt from the label)

Use(s) to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-493

What is NDC 42291-493?: 42291-493 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 4 mg/.1mL spray, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Naloxone Hydrochloride.
What is the active ingredient?: Naloxone hydrochloride.
Who is the labeler?: AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naloxone Hydrochloride?: 77 other product NDCs are listed under this name. See all Naloxone Hydrochloride 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 Naloxone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
naloxone hydrochloride	Naloxone hydrochloride .4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Lifestar Pharma LLC	70756-850	70756-0850-1070756-0850-2570756-0850-82
Naloxone Hydrochloride	Naloxone hydrochloride .4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Henry Schein, Inc.	0404-9773	00404-9773-01
Naloxone Hydrochloride	Naloxone hydrochloride .4 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6193	00641-6193-10
naloxone hydrochloride	Naloxone hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Baxter Healthcare Corporation	43066-142	43066-0142-10
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	BluePoint Laboratories	68001-645	68001-0645-45
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	Strategic Sourcing Services LLC	70677-1283	70677-1283-01
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	AMERISOURCE BERGEN	46122-812	46122-0812-71
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	Spray, MeteredNasal	Actavis Pharma, Inc.	0591-3871	00591-3871-99
Naloxone Hydrochloride	Naloxone hydrochloride 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Par Health USA, LLC	42023-224	42023-0224-01
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	Spray, MeteredNasal	Teva Pharmaceuticals, Inc.	0480-3478	00480-3478-68

All 78 Naloxone Hydrochloride NDCs

Other NDCs under ANDA 217992

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

FDA NDC Directory listings under ANDA 217992
Product	Strength	Form · route	Labeler	Product NDC
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	Walgreen Co.	0363-2140
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	CVS Pharmacy, Inc	51316-210
Naloxone Hydrochloridenaloxone	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	Amneal Pharmaceuticals NY LLC	60219-2104
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	Amneal Pharmaceuticals LLC	69238-2104