Label: NALOXONE spray
- NDC Code(s): 43674-003-02
- Packager: Summit Biosciences Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 12, 2023
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- Official Label (Printer Friendly)
- PATIENT PACKAGE INSERT
- INDICATIONS & USAGE
- TRADENAME (Naloxone Hydrochloride) Nasal Spray
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INGREDIENTS AND APPEARANCE
NALOXONE
naloxone sprayProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43674-003 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE 10 mg in 0.1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) HYDROCHLORIC ACID (UNII: QTT17582CB) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43674-003-02 2 in 1 CARTON 06/28/2024 1 1 in 1 BLISTER PACK 1 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 NDA NDA215487 06/28/2024 Labeler - Summit Biosciences Inc. (832920081) Registrant - Summit Biosciences Inc. (832920081) Establishment Name Address ID/FEI Business Operations Summit Biosciences Inc. 832920081 analysis(43674-003) , label(43674-003) , manufacture(43674-003) , pack(43674-003)