naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler padagis israel pharmaceuticals ltd
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.1mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-578
Product ID 45802-578_10534467-f259-44bb-bdf7-b09de54411ed
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211951
Listing Expiration 2027-12-31
Marketing Start 2023-07-30

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802578
Hyphenated Format 45802-578

Supplemental Identifiers

RxCUI
1725059
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 ANDA211951 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.1mL
source: ndc
Packaging
  • 24 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-24) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00)
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-84) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00)
source: ndc

Packages (2)

45802-578-24 24 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-24) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00) 45802-578-84 2 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-84) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00)

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": "10534467-f259-44bb-bdf7-b09de54411ed", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["b5d40220-f194-4835-b70c-f304ecb222d5"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-24)  / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00)", "package_ndc": "45802-578-24", "marketing_start_date": "20250801"}, {"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-84)  / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00)", "package_ndc": "45802-578-84", "marketing_start_date": "20230730"}], "brand_name": "NALOXONE HYDROCHLORIDE", "product_id": "45802-578_10534467-f259-44bb-bdf7-b09de54411ed", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "45802-578", "generic_name": "naloxone hydrochloride", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "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": "20230730", "listing_expiration_date": "20271231"}