naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler par health usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride 1 mg/mL

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 42023-224
Product ID 42023-224_3b2e17da-1874-451c-80eb-1c87a62e585c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215964
Listing Expiration 2026-12-31
Marketing Start 2024-11-05

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023224
Hyphenated Format 42023-224

Supplemental Identifiers

RxCUI
1191250
UPC
0342023179050
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 (source: ndc)
Generic Name naloxone hydrochloride (source: ndc)
Application Number ANDA215964 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (42023-224-01) / 2 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

42023-224-01 1 SYRINGE, GLASS in 1 CARTON (42023-224-01) / 2 mL in 1 SYRINGE, GLASS

Ingredients (1)

naloxone hydrochloride (1 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": "3b2e17da-1874-451c-80eb-1c87a62e585c", "openfda": {"upc": ["0342023179050"], "unii": ["F850569PQR"], "rxcui": ["1191250"], "spl_set_id": ["3ae08e26-223b-4971-b2f1-f1e183a3f930"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (42023-224-01)  / 2 mL in 1 SYRINGE, GLASS", "package_ndc": "42023-224-01", "marketing_start_date": "20241105"}], "brand_name": "Naloxone Hydrochloride", "product_id": "42023-224_3b2e17da-1874-451c-80eb-1c87a62e585c", "dosage_form": "INJECTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "42023-224", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA215964", "marketing_category": "ANDA", "marketing_start_date": "20241105", "listing_expiration_date": "20261231"}