naloxone hcl

Generic: naloxone hcl

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hcl
Generic Name naloxone hcl
Labeler hf acquisition co llc, dba healthfirst
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.1mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1620
Product ID 51662-1620_100bc933-5bf3-8de2-e063-6294a90a7ba6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211951
Listing Expiration 2026-12-31
Marketing Start 2023-04-10

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621620
Hyphenated Format 51662-1620

Supplemental Identifiers

RxCUI
1725059
UPC
0345802811004
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 hcl (source: ndc)
Generic Name naloxone hcl (source: ndc)
Application Number ANDA211951 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.1mL
source: ndc
Packaging
  • .1 mL in 1 VIAL, SINGLE-DOSE (51662-1620-1)
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (51662-1620-2) / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

51662-1620-1 .1 mL in 1 VIAL, SINGLE-DOSE (51662-1620-1) 51662-1620-2 2 VIAL, SINGLE-DOSE in 1 CARTON (51662-1620-2) / .1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

naloxone hydrochloride (4 mg/.1mL)

Linked Drug Pages (1)

NALOXONE HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "100bc933-5bf3-8de2-e063-6294a90a7ba6", "openfda": {"upc": ["0345802811004"], "unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["f8fcda15-8ba6-e66a-e053-6294a90a385c"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": ".1 mL in 1 VIAL, SINGLE-DOSE (51662-1620-1)", "package_ndc": "51662-1620-1", "marketing_start_date": "20230410"}, {"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (51662-1620-2)  / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1620-2", "marketing_start_date": "20230410"}], "brand_name": "NALOXONE HCl", "product_id": "51662-1620_100bc933-5bf3-8de2-e063-6294a90a7ba6", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "51662-1620", "generic_name": "NALOXONE HCl", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALOXONE HCl", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "4 mg/.1mL"}], "application_number": "ANDA211951", "marketing_category": "ANDA", "marketing_start_date": "20230410", "listing_expiration_date": "20261231"}