naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

naloxone hydrochloride 1 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-992
Product ID 67457-992_aa56cac5-0a95-4536-832d-5f24e921118f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213843
Listing Expiration 2026-12-31
Marketing Start 2022-12-02

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457992
Hyphenated Format 67457-992

Supplemental Identifiers

RxCUI
1191250
UPC
0367457992020
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 ANDA213843 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (67457-992-02) / 2 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

67457-992-02 1 SYRINGE, GLASS in 1 CARTON (67457-992-02) / 2 mL in 1 SYRINGE, GLASS

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": "aa56cac5-0a95-4536-832d-5f24e921118f", "openfda": {"upc": ["0367457992020"], "unii": ["F850569PQR"], "rxcui": ["1191250"], "spl_set_id": ["7faaedb3-227b-408d-b772-6b326638b00e"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (67457-992-02)  / 2 mL in 1 SYRINGE, GLASS", "package_ndc": "67457-992-02", "marketing_start_date": "20221202"}], "brand_name": "Naloxone Hydrochloride", "product_id": "67457-992_aa56cac5-0a95-4536-832d-5f24e921118f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "67457-992", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA213843", "marketing_category": "ANDA", "marketing_start_date": "20221202", "listing_expiration_date": "20261231"}