naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler henry schein, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9773
Product ID 0404-9773_dfa64508-45a2-41b2-b20f-eccda5e05c29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218404
Listing Expiration 2026-12-31
Marketing Start 2025-10-28

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049773
Hyphenated Format 0404-9773

Supplemental Identifiers

RxCUI
1659929
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 ANDA218404 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9773-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9773-01 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9773-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

naloxone hydrochloride (.4 mg/mL)

Linked Drug Pages (1)

NALOXONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "dfa64508-45a2-41b2-b20f-eccda5e05c29", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1659929"], "spl_set_id": ["ddeebc32-9aab-4a2f-8c87-74335d17d5ef"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9773-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9773-01", "marketing_start_date": "20251028"}], "brand_name": "NALOXONE HYDROCHLORIDE", "product_id": "0404-9773_dfa64508-45a2-41b2-b20f-eccda5e05c29", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "0404-9773", "generic_name": "naloxone hydrochloride", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALOXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA218404", "marketing_category": "ANDA", "marketing_start_date": "20251028", "listing_expiration_date": "20261231"}