naloxone hydrochloride injection, usp, auto-injector

Generic: naloxone hydrochloride

Labeler: kaleo, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride injection, usp, auto-injector
Generic Name naloxone hydrochloride
Labeler kaleo, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride 10 mg/.4mL

Manufacturer
Kaleo, Inc.

Identifiers & Regulatory

Product NDC 60842-002
Product ID 60842-002_04afe7f9-83ba-4269-a6ce-3bcc61a106d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215457
Listing Expiration 2026-12-31
Marketing Start 2022-02-28

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60842002
Hyphenated Format 60842-002

Supplemental Identifiers

RxCUI
2596175
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 naloxone hydrochloride injection, usp, auto-injector (source: ndc)
Generic Name naloxone hydrochloride (source: ndc)
Application Number NDA215457 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/.4mL
source: ndc
Packaging
  • 10 DOSE PACK in 1 CARTON (60842-002-02) / .4 mL in 1 DOSE PACK
source: ndc

Packages (1)

60842-002-02 10 DOSE PACK in 1 CARTON (60842-002-02) / .4 mL in 1 DOSE PACK

Ingredients (1)

naloxone hydrochloride (10 mg/.4mL)

Linked Drug Pages (1)

Naloxone Hydrochloride Injection, USP, Auto-Injector ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "04afe7f9-83ba-4269-a6ce-3bcc61a106d8", "openfda": {"unii": ["F850569PQR"], "rxcui": ["2596175"], "spl_set_id": ["b5463553-b775-47a3-8d10-31e01ca1ec72"], "manufacturer_name": ["Kaleo, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 DOSE PACK in 1 CARTON (60842-002-02)  / .4 mL in 1 DOSE PACK", "package_ndc": "60842-002-02", "marketing_start_date": "20220228"}], "brand_name": "Naloxone Hydrochloride Injection, USP, Auto-Injector", "product_id": "60842-002_04afe7f9-83ba-4269-a6ce-3bcc61a106d8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "60842-002", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Kaleo, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride Injection, USP, Auto-Injector", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "10 mg/.4mL"}], "application_number": "NDA215457", "marketing_category": "NDA", "marketing_start_date": "20220228", "listing_expiration_date": "20261231"}