naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler bryant ranch prepack
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.1mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9321
Product ID 63629-9321_2b9592cc-ed48-4703-a8d2-85f0a8792d19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211951
Listing Expiration 2026-12-31
Marketing Start 2022-06-21

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636299321
Hyphenated Format 63629-9321

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 (63629-9321-1) / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63629-9321-1 2 VIAL, SINGLE-DOSE in 1 CARTON (63629-9321-1) / .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": "2b9592cc-ed48-4703-a8d2-85f0a8792d19", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["73edcc70-d988-4f66-a09a-8d23042283c3"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (63629-9321-1)  / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63629-9321-1", "marketing_start_date": "20220707"}], "brand_name": "NALOXONE HYDROCHLORIDE", "product_id": "63629-9321_2b9592cc-ed48-4703-a8d2-85f0a8792d19", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "63629-9321", "generic_name": "naloxone hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALOXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "4 mg/.1mL"}], "application_number": "ANDA211951", "marketing_category": "ANDA", "marketing_start_date": "20220621", "listing_expiration_date": "20261231"}