naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

naloxone hydrochloride .4 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-327
Product ID 55150-327_c0bb9ae0-109a-4e3f-b300-a94e2721dddb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212455
Listing Expiration 2026-12-31
Marketing Start 2019-10-15

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150327
Hyphenated Format 55150-327

Supplemental Identifiers

RxCUI
1659929
UPC
0355150327010
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 ANDA212455 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-327-10) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-327-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

55150-327-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-327-10) / 1 mL in 1 VIAL, SINGLE-DOSE 55150-327-25 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-327-25) / 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": "c0bb9ae0-109a-4e3f-b300-a94e2721dddb", "openfda": {"upc": ["0355150327010"], "unii": ["F850569PQR"], "rxcui": ["1659929"], "spl_set_id": ["c7fa8d4f-28a7-4ef5-aef8-cbd4328ce599"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-327-10)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-327-10", "marketing_start_date": "20191015"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-327-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-327-25", "marketing_start_date": "20191015"}], "brand_name": "Naloxone Hydrochloride", "product_id": "55150-327_c0bb9ae0-109a-4e3f-b300-a94e2721dddb", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "55150-327", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Eugia US LLC", "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": "20191015", "listing_expiration_date": "20261231"}