Naloxone by Summit Biosciences Inc. NALOXONE spray

Naloxone by

Drug Labeling and Warnings

Naloxone by is a Prescription medication manufactured, distributed, or labeled by Summit Biosciences Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PATIENT PACKAGE INSERT

INDICATIONS & USAGE

TRADENAME (Naloxone Hydrochloride) Nasal Spray

INGREDIENTS AND APPEARANCE

NALOXONE 
naloxone spray

Product 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)