Drugplain

NARCAN 4 mg/.1mL

naloxone hydrochloride nasal · SPRAY · Sportpharm LLC

1 Recall on Record
Plain English

NARCAN is a spray containing naloxone hydrochloride nasal at 4 mg/.1mL, taken nasal. Manufactured by Sportpharm LLC.

Key Facts

Brand Name
NARCAN
Generic Name
naloxone hydrochloride nasal
NDC Code (Product)
85766-076
Manufacturer
Sportpharm LLC
Strength
4 mg/.1mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
NDA208411
Marketing Start
08/28/2023

Recall History

1 Recall on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea366 reports
fatigue344 reports
pain335 reports
death289 reports
vomiting280 reports
diarrhoea256 reports
dyspnoea240 reports
off label use226 reports
toxicity to various agents213 reports
drug ineffective210 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

DIRECTIONS For opioid emergencies, call 911. For questions on NARCAN, call 1-844-4NARCAN (1-844-462-7226) or go to WWW.NARCAN.COM . ©2023 Emergent Devices Inc. EMERGENT® and NARCAN® are registered trademarks of Emergent BioSolutions Inc, or its subsidiaries. Other Information • store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F) • do not freeze • avoid excessive heat above 40°C (104°F) • protect from light • the product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged. Directions Directions

Warnings

When using this product some people may experience symptoms when they wake up, such as, shaking, sweating, nausea, or feeling angry. This is to be expected.

Frequently Asked Questions

What is NARCAN used for?

NARCAN contains naloxone hydrochloride nasal. It is a spray taken nasal. Consult your doctor for specific uses.

Is NARCAN a controlled substance?

NARCAN is not classified as a controlled substance by the DEA.

What is the generic name for NARCAN?

The generic name for NARCAN is naloxone hydrochloride nasal. There are 1 other brand versions of naloxone hydrochloride nasal.

What is the NDC code for NARCAN 4 mg/.1mL?

The NDC (National Drug Code) for NARCAN 4 mg/.1mL is 85766-076, listed by Sportpharm LLC.

Product NDC

85766-076

Package NDC

85766-076-02

Other NARCAN Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)