naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-114
Product ID 76045-114_6503f42d-3303-497a-9653-4b6d89bf7833
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213573
Listing Expiration 2026-12-31
Marketing Start 2024-04-02

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76045114
Hyphenated Format 76045-114

Supplemental Identifiers

RxCUI
1191250 2679504
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 ANDA213573 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 24 SYRINGE in 1 CARTON (76045-114-10) / 1 mL in 1 SYRINGE (76045-114-01)
source: ndc

Packages (1)

76045-114-10 24 SYRINGE in 1 CARTON (76045-114-10) / 1 mL in 1 SYRINGE (76045-114-01)

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": "6503f42d-3303-497a-9653-4b6d89bf7833", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1191250", "2679504"], "spl_set_id": ["201fdedf-1736-4e52-9d7d-de14292547fd"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 SYRINGE in 1 CARTON (76045-114-10)  / 1 mL in 1 SYRINGE (76045-114-01)", "package_ndc": "76045-114-10", "marketing_start_date": "20240402"}], "brand_name": "Naloxone Hydrochloride", "product_id": "76045-114_6503f42d-3303-497a-9653-4b6d89bf7833", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "76045-114", "generic_name": "NALOXONE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA213573", "marketing_category": "ANDA", "marketing_start_date": "20240402", "listing_expiration_date": "20261231"}