Label: NALOXONE HYDROCHLORIDE spray
- NDC Code(s): 50090-6963-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 45802-578
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 27, 2023
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- Official Label (Printer Friendly)
- Active Ingredient (in each spray)
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- Purpose
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Directions
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- Other information
- Inactive Ingredients
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- HOW SUPPLIED
- naloxone hydrochloride
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INGREDIENTS AND APPEARANCE
NALOXONE HYDROCHLORIDE
naloxone hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-6963(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:50090-6963-0 2 in 1 CARTON 12/20/2023 1 .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 - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-6963)