naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler advanced rx of tennessee, llc
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.1mL

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0409
Product ID 80425-0409_1be2d8f6-f643-69a6-e063-6294a90a327f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211951
Listing Expiration 2026-12-31
Marketing Start 2024-06-27

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250409
Hyphenated Format 80425-0409

Supplemental Identifiers

RxCUI
1725059
UNII
F850569PQR

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 (source: ndc)
Generic Name naloxone hydrochloride (source: ndc)
Application Number ANDA211951 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.1mL
source: ndc
Packaging
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (80425-0409-1) / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

80425-0409-1 2 VIAL, SINGLE-DOSE in 1 CARTON (80425-0409-1) / .1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

naloxone hydrochloride (4 mg/.1mL)

Linked Drug Pages (1)

NALOXONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "1be2d8f6-f643-69a6-e063-6294a90a327f", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["1be2e38b-55ca-abea-e063-6394a90ac548"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (80425-0409-1)  / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "80425-0409-1", "marketing_start_date": "20240627"}], "brand_name": "NALOXONE HYDROCHLORIDE", "product_id": "80425-0409_1be2d8f6-f643-69a6-e063-6294a90a327f", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "80425-0409", "generic_name": "naloxone hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NALOXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "4 mg/.1mL"}], "application_number": "ANDA211951", "marketing_category": "ANDA", "marketing_start_date": "20240627", "listing_expiration_date": "20261231"}