naloxone hydrochloride

Generic: naloxone hydrochloride

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

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1544
Product ID 51662-1544_10352ea7-15c5-5c6c-e063-6394a90ae130
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212455
Listing Expiration 2026-12-31
Marketing Start 2021-08-08

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621544
Hyphenated Format 51662-1544

Supplemental Identifiers

RxCUI
1659929
UPC
0355150327010
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 hydrochloride (source: ndc)
Generic Name naloxone hydrochloride (source: ndc)
Application Number ANDA212455 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-DOSE (51662-1544-1)
  • 10 POUCH in 1 CASE (51662-1544-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1544-2) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

51662-1544-1 1 mL in 1 VIAL, SINGLE-DOSE (51662-1544-1) 51662-1544-3 10 POUCH in 1 CASE (51662-1544-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1544-2) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "10352ea7-15c5-5c6c-e063-6394a90ae130", "openfda": {"upc": ["0355150327010"], "unii": ["F850569PQR"], "rxcui": ["1659929"], "spl_set_id": ["c90e2d85-ed94-2c00-e053-2a95a90ad2a0"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (51662-1544-1)", "package_ndc": "51662-1544-1", "marketing_start_date": "20210808"}, {"sample": false, "description": "10 POUCH in 1 CASE (51662-1544-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1544-2)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1544-3", "marketing_start_date": "20220422"}], "brand_name": "NALOXONE HYDROCHLORIDE", "product_id": "51662-1544_10352ea7-15c5-5c6c-e063-6394a90ae130", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "51662-1544", "generic_name": "NALOXONE HYDROCHLORIDE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALOXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA212455", "marketing_category": "ANDA", "marketing_start_date": "20210808", "listing_expiration_date": "20261231"}