naloxone hydrochloride

Generic: naloxone

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone
Labeler amneal pharmaceuticals ny llc
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.1mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-2104
Product ID 60219-2104_a79738c5-1989-43c7-856b-f284c654c9c0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217992
Listing Expiration 2027-12-31
Marketing Start 2024-04-24

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602192104
Hyphenated Format 60219-2104

Supplemental Identifiers

RxCUI
1725059
UPC
0360219210479
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 (source: ndc)
Application Number ANDA217992 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.1mL
source: ndc
Packaging
  • 2 VIAL in 1 CARTON (60219-2104-7) / .1 mL in 1 VIAL (60219-2104-1)
source: ndc

Packages (1)

60219-2104-7 2 VIAL in 1 CARTON (60219-2104-7) / .1 mL in 1 VIAL (60219-2104-1)

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": "a79738c5-1989-43c7-856b-f284c654c9c0", "openfda": {"upc": ["0360219210479"], "unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["8779a073-dc6e-410a-9959-fd370f0079f9"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL in 1 CARTON (60219-2104-7)  / .1 mL in 1 VIAL (60219-2104-1)", "package_ndc": "60219-2104-7", "marketing_start_date": "20240424"}], "brand_name": "Naloxone Hydrochloride", "product_id": "60219-2104_a79738c5-1989-43c7-856b-f284c654c9c0", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "60219-2104", "generic_name": "Naloxone", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "4 mg/.1mL"}], "application_number": "ANDA217992", "marketing_category": "ANDA", "marketing_start_date": "20240424", "listing_expiration_date": "20271231"}