kloxxado

Generic: naloxone hcl

Labeler: hikma specialty usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kloxxado
Generic Name naloxone hcl
Labeler hikma specialty usa inc.
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 8 mg/.1mL

Manufacturer
Hikma Specialty USA Inc.

Identifiers & Regulatory

Product NDC 59467-679
Product ID 59467-679_da424329-9a63-4df3-bced-4157d2086e20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212045
Listing Expiration 2026-12-31
Marketing Start 2021-08-03

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59467679
Hyphenated Format 59467-679

Supplemental Identifiers

RxCUI
2540703 2540709
UPC
0359467679015
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 kloxxado (source: ndc)
Generic Name naloxone hcl (source: ndc)
Application Number NDA212045 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/.1mL
source: ndc
Packaging
  • .1 mL in 1 VIAL, SINGLE-DOSE (59467-679-01)
source: ndc

Packages (1)

59467-679-01 .1 mL in 1 VIAL, SINGLE-DOSE (59467-679-01)

Ingredients (1)

naloxone hydrochloride (8 mg/.1mL)

Linked Drug Pages (1)

KLOXXADO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "da424329-9a63-4df3-bced-4157d2086e20", "openfda": {"upc": ["0359467679015"], "unii": ["F850569PQR"], "rxcui": ["2540703", "2540709"], "spl_set_id": ["ebf0f833-c1c0-487c-8f29-01fa8c61b6cb"], "manufacturer_name": ["Hikma Specialty USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": ".1 mL in 1 VIAL, SINGLE-DOSE (59467-679-01)", "package_ndc": "59467-679-01", "marketing_start_date": "20210803"}], "brand_name": "KLOXXADO", "product_id": "59467-679_da424329-9a63-4df3-bced-4157d2086e20", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "59467-679", "generic_name": "Naloxone HCL", "labeler_name": "Hikma Specialty USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KLOXXADO", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "8 mg/.1mL"}], "application_number": "NDA212045", "marketing_category": "NDA", "marketing_start_date": "20210803", "listing_expiration_date": "20261231"}