naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: bpi labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler bpi labs llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride 1 mg/mL

Manufacturer
BPI Labs LLC

Identifiers & Regulatory

Product NDC 54288-124
Product ID 54288-124_f0223f84-ddc4-45a8-94e8-22cd1a39f19e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216977
Listing Expiration 2026-12-31
Marketing Start 2023-11-15

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54288124
Hyphenated Format 54288-124

Supplemental Identifiers

RxCUI
1191250
UPC
0354288124010
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 ANDA216977 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 PACKAGE in 1 CARTON (54288-124-01) / 2 mL in 1 PACKAGE
  • 10 PACKAGE in 1 CARTON (54288-124-10) / 2 mL in 1 PACKAGE
source: ndc

Packages (2)

54288-124-01 1 PACKAGE in 1 CARTON (54288-124-01) / 2 mL in 1 PACKAGE 54288-124-10 10 PACKAGE in 1 CARTON (54288-124-10) / 2 mL in 1 PACKAGE

Ingredients (1)

naloxone hydrochloride (1 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": "f0223f84-ddc4-45a8-94e8-22cd1a39f19e", "openfda": {"upc": ["0354288124010"], "unii": ["F850569PQR"], "rxcui": ["1191250"], "spl_set_id": ["5de44ee7-6525-4857-9a67-8882e96dbeb5"], "manufacturer_name": ["BPI Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 PACKAGE in 1 CARTON (54288-124-01)  / 2 mL in 1 PACKAGE", "package_ndc": "54288-124-01", "marketing_start_date": "20231115"}, {"sample": false, "description": "10 PACKAGE in 1 CARTON (54288-124-10)  / 2 mL in 1 PACKAGE", "package_ndc": "54288-124-10", "marketing_start_date": "20231115"}], "brand_name": "Naloxone Hydrochloride", "product_id": "54288-124_f0223f84-ddc4-45a8-94e8-22cd1a39f19e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "54288-124", "generic_name": "Naloxone Hydrochloride", "labeler_name": "BPI Labs LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA216977", "marketing_category": "ANDA", "marketing_start_date": "20231115", "listing_expiration_date": "20261231"}