naloxone hydrochloride

Generic: naloxone hydrochloride

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

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
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 69238-2104
Product ID 69238-2104_578cd3f4-d52a-46cb-bdca-88ab555be347
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 692382104
Hyphenated Format 69238-2104

Supplemental Identifiers

RxCUI
1725059
UPC
0369238210477
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 ANDA217992 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.1mL
source: ndc
Packaging
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (69238-2104-7) / .1 mL in 1 VIAL, SINGLE-DOSE (69238-2104-1)
source: ndc

Packages (1)

69238-2104-7 2 VIAL, SINGLE-DOSE in 1 CARTON (69238-2104-7) / .1 mL in 1 VIAL, SINGLE-DOSE (69238-2104-1)

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": "578cd3f4-d52a-46cb-bdca-88ab555be347", "openfda": {"upc": ["0369238210477"], "unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["8091a73d-9ecd-4578-a57b-5d85a2c5a16a"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (69238-2104-7)  / .1 mL in 1 VIAL, SINGLE-DOSE (69238-2104-1)", "package_ndc": "69238-2104-7", "marketing_start_date": "20240424"}], "brand_name": "Naloxone Hydrochloride", "product_id": "69238-2104_578cd3f4-d52a-46cb-bdca-88ab555be347", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "69238-2104", "generic_name": "Naloxone Hydrochloride", "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"}