naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler a-s medication solutions
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.1mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6963
Product ID 50090-6963_7a0088db-1e25-49db-9a22-c99cd6adfd8f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211951
Listing Expiration 2026-12-31
Marketing Start 2023-07-30

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906963
Hyphenated Format 50090-6963

Supplemental Identifiers

RxCUI
1725059
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 ANDA211951 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.1mL
source: ndc
Packaging
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (50090-6963-0) / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

50090-6963-0 2 VIAL, SINGLE-DOSE in 1 CARTON (50090-6963-0) / .1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

naloxone hydrochloride (4 mg/.1mL)

Linked Drug Pages (1)

NALOXONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "7a0088db-1e25-49db-9a22-c99cd6adfd8f", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["46f27d04-d4d2-4ef1-9cc5-4d58f4056f06"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (50090-6963-0)  / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50090-6963-0", "marketing_start_date": "20231220"}], "brand_name": "NALOXONE HYDROCHLORIDE", "product_id": "50090-6963_7a0088db-1e25-49db-9a22-c99cd6adfd8f", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "50090-6963", "generic_name": "naloxone hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NALOXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "4 mg/.1mL"}], "application_number": "ANDA211951", "marketing_category": "ANDA", "marketing_start_date": "20230730", "listing_expiration_date": "20261231"}