naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

naloxone hydrochloride .4 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-071
Product ID 84549-071_3a388817-cca6-540d-e063-6294a90a6b35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207633
Listing Expiration 2026-12-31
Marketing Start 2017-08-08

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84549071
Hyphenated Format 84549-071

Supplemental Identifiers

RxCUI
1659929
UNII
F850569PQR

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 ANDA207633 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL (84549-071-10)
source: ndc

Packages (1)

84549-071-10 1 mL in 1 VIAL (84549-071-10)

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": "3a388817-cca6-540d-e063-6294a90a6b35", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1659929"], "spl_set_id": ["3856ea66-29b8-8fc2-e063-6394a90ac33a"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL (84549-071-10)", "package_ndc": "84549-071-10", "marketing_start_date": "20250827"}], "brand_name": "Naloxone Hydrochloride", "product_id": "84549-071_3a388817-cca6-540d-e063-6294a90a6b35", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "84549-071", "generic_name": "Naloxone Hydrochloride", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA207633", "marketing_category": "ANDA", "marketing_start_date": "20170808", "listing_expiration_date": "20261231"}