NARCAN

Basic Information

Product Name

NARCAN

FDA Product Code

55700-457

Regulatory Information

NDC Product Code

55700-457

Application Number

NDA208411

Marketing Category

C73594

Effective Date

November 28, 2016

Territorial Authority

USA

FDA Title

NARCAN (naloxone hydrochloride) Nasal Spray These highlights do not include all the information needed to use NARCAN NASAL SPRAY safely and effectively. See full prescribing information for NARCAN® NASAL SPRAY.NARCAN® (naloxone hydrochloride) nasal sprayInitial U.S. Approval: 1971

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

NALOXONE HYDROCHLORIDE

Quantity: 4 mg in 0.1 mL

Code: F850569PQR

Class Code: ACTIB

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: CNTM

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

NALOXONE

Code: 36B82AMQ7N

Basic Information

Regulatory Information

Company Information

Active Ingredients

BENZALKONIUM CHLORIDE

EDETATE DISODIUM

SODIUM CHLORIDE

WATER

Active Moieties

NALOXONE