naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler northstar rxllc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-590
Product ID 72603-590_3fb9f554-709f-4f32-96fc-60cb4b867ae5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218404
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603590
Hyphenated Format 72603-590

Supplemental Identifiers

RxCUI
1659929
UPC
0372603590012 0372603590104
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 ANDA218404 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (72603-590-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72603-590-01)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (72603-590-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72603-590-01)
source: ndc

Packages (2)

72603-590-10 10 VIAL, SINGLE-DOSE in 1 CARTON (72603-590-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72603-590-01) 72603-590-25 25 VIAL, SINGLE-DOSE in 1 CARTON (72603-590-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72603-590-01)

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": "3fb9f554-709f-4f32-96fc-60cb4b867ae5", "openfda": {"upc": ["0372603590012", "0372603590104"], "unii": ["F850569PQR"], "rxcui": ["1659929"], "spl_set_id": ["d4c44b74-4e36-4b63-80eb-64ce99ccb39f"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (72603-590-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (72603-590-01)", "package_ndc": "72603-590-10", "marketing_start_date": "20240701"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (72603-590-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (72603-590-01)", "package_ndc": "72603-590-25", "marketing_start_date": "20240701"}], "brand_name": "naloxone hydrochloride", "product_id": "72603-590_3fb9f554-709f-4f32-96fc-60cb4b867ae5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "72603-590", "generic_name": "naloxone hydrochloride", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "naloxone hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA218404", "marketing_category": "ANDA", "marketing_start_date": "20240701", "listing_expiration_date": "20261231"}