narcan

Generic: naloxone hydrochloride nasal

Labeler: emergent devices inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name narcan
Generic Name naloxone hydrochloride nasal
Labeler emergent devices inc.
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.1mL

Manufacturer
Emergent Devices Inc.

Identifiers & Regulatory

Product NDC 69547-627
Product ID 69547-627_eca68b75-c15c-4ee0-a352-a4ec66e57424
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA208411
Listing Expiration 2026-12-31
Marketing Start 2023-08-28

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69547627
Hyphenated Format 69547-627

Supplemental Identifiers

RxCUI
1725059 1725064
UNII
F850569PQR

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name narcan (source: ndc)
Generic Name naloxone hydrochloride nasal (source: ndc)
Application Number NDA208411 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.1mL
source: ndc
Packaging
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-02) / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

69547-627-02 2 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-02) / .1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

naloxone hydrochloride (4 mg/.1mL)

Linked Drug Pages (1)

NARCAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "eca68b75-c15c-4ee0-a352-a4ec66e57424", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1725059", "1725064"], "spl_set_id": ["a0ebc83d-2892-40de-bc0a-775ce90b30db"], "manufacturer_name": ["Emergent Devices Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-02)  / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "69547-627-02", "marketing_start_date": "20230828"}], "brand_name": "NARCAN", "product_id": "69547-627_eca68b75-c15c-4ee0-a352-a4ec66e57424", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "69547-627", "generic_name": "naloxone hydrochloride nasal", "labeler_name": "Emergent Devices Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NARCAN", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "4 mg/.1mL"}], "application_number": "NDA208411", "marketing_category": "NDA", "marketing_start_date": "20230828", "listing_expiration_date": "20261231"}