naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

naloxone hydrochloride .4 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-071
Product ID 70069-071_52551e7c-39ae-4d67-be09-97a5368ba6e4
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 70069071
Hyphenated Format 70069-071

Supplemental Identifiers

RxCUI
1659929
UPC
0370069071014
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 ANDA207633 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (70069-071-10) / 1 mL in 1 VIAL (70069-071-01)
source: ndc

Packages (1)

70069-071-10 10 VIAL in 1 CARTON (70069-071-10) / 1 mL in 1 VIAL (70069-071-01)

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": "52551e7c-39ae-4d67-be09-97a5368ba6e4", "openfda": {"upc": ["0370069071014"], "unii": ["F850569PQR"], "rxcui": ["1659929"], "spl_set_id": ["dfa48492-d83b-48cc-9ad1-bdc0c2ac9931"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70069-071-10)  / 1 mL in 1 VIAL (70069-071-01)", "package_ndc": "70069-071-10", "marketing_start_date": "20170808"}], "brand_name": "Naloxone Hydrochloride", "product_id": "70069-071_52551e7c-39ae-4d67-be09-97a5368ba6e4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "70069-071", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "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"}