naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: bluepoint laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler bluepoint laboratories
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.1mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-645
Product ID 68001-645_402a0c78-5e4d-39a0-e063-6294a90a74ee
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211951
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001645
Hyphenated Format 68001-645

Supplemental Identifiers

RxCUI
1725059
UPC
0368001645454
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 ANDA211951 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.1mL
source: ndc
Packaging
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (68001-645-45) / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68001-645-45 2 VIAL, SINGLE-DOSE in 1 CARTON (68001-645-45) / .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": "402a0c78-5e4d-39a0-e063-6294a90a74ee", "openfda": {"upc": ["0368001645454"], "unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["327004b0-560a-84d0-e063-6294a90aa743"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (68001-645-45)  / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68001-645-45", "marketing_start_date": "20250501"}], "brand_name": "NALOXONE HYDROCHLORIDE", "product_id": "68001-645_402a0c78-5e4d-39a0-e063-6294a90a74ee", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "68001-645", "generic_name": "naloxone hydrochloride", "labeler_name": "BluePoint Laboratories", "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": "20250501", "listing_expiration_date": "20261231"}