naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-814
Product ID 71288-814_56d28c41-a00f-46f3-9c13-c62c20954555
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214211
Listing Expiration 2026-12-31
Marketing Start 2026-01-01

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288814
Hyphenated Format 71288-814

Supplemental Identifiers

RxCUI
2679504
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 ANDA214211 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (71288-814-81) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

71288-814-81 10 SYRINGE in 1 CARTON (71288-814-81) / 1 mL in 1 SYRINGE

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": "56d28c41-a00f-46f3-9c13-c62c20954555", "openfda": {"unii": ["F850569PQR"], "rxcui": ["2679504"], "spl_set_id": ["c2daaefa-6c24-4e91-9176-61e9713069fa"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (71288-814-81)  / 1 mL in 1 SYRINGE", "package_ndc": "71288-814-81", "marketing_start_date": "20260101"}], "brand_name": "Naloxone Hydrochloride", "product_id": "71288-814_56d28c41-a00f-46f3-9c13-c62c20954555", "dosage_form": "INJECTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "71288-814", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA214211", "marketing_category": "ANDA", "marketing_start_date": "20260101", "listing_expiration_date": "20261231"}