Label: NALOXONE HYDROCHLORIDE spray
- NDC Code(s): 45802-578-00, 45802-578-24, 45802-578-84
- Packager: Padagis Israel Pharmaceuticals Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 6, 2026
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- Official Label (Printer Friendly)
- Active Ingredient (in each spray)
- Purpose
- Uses
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Directions
EMERGENCY TREATMENT OF OPIOID OVERDOSE
Important:
- •
- For use in the nose only
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- Do not test nasal spray device before use
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- 1 nasal spray device contains 1 dose of medicine
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- Each device sprays 1 time only
For opioid emergencies, call 911. For questions on Naloxone HCl Nasal Spray 4 mg, call Padagis® at 1-866-634-9120 or go to www.padagisnaloxone.com.
- Warning
- Other information
- Inactive Ingredients
- Questions?
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Package/Label Principal Display Panel
NDC 45802-578-84
Compare to NARCAN® active ingredient
Padagis
Naloxone
Naloxone HCl Nasal Spray 4 mg
Emergency Treatment of Opioid Overdose
Original Prescription Strength
Easy to Use
Can Save a Life
Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency
2 SINGLE-DOSE NASAL SPRAY DEVICES
0.003 FL OZ (0.1mL) EACH
FOR USE IN NOSE ONLY
DO NOT TEST NASAL SPRAY DEVICE BEFORE USE
1 NASAL SPRAY DEVICE CONTAINS 1 DOSE OF MEDICINE
EACH DEVICE SPRAYS 1 TIME ONLY
SAFE TO USE EVEN IF OPIOIDS ARE NOT PRESENT
Distributed by Padagis®
Allegan, MI 4901064QJ8 RT C4
Product of USA
64Q00 RT QS5
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INGREDIENTS AND APPEARANCE
NALOXONE HYDROCHLORIDE
naloxone hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-578 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE 4 mg in 0.1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROCHLORIC ACID (UNII: QTT17582CB) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-578-84 2 in 1 CARTON 07/30/2023 1 NDC:45802-578-00 0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:45802-578-24 24 in 1 CARTON 08/01/2025 2 NDC:45802-578-00 0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211951 07/30/2023 Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)






