rextovy

Generic: naloxone hydrochloride

Labeler: international medication systems, ltd.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rextovy
Generic Name naloxone hydrochloride
Labeler international medication systems, ltd.
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.25mL

Manufacturer
International Medication Systems, Ltd.

Identifiers & Regulatory

Product NDC 76329-3669
Product ID 76329-3669_25c8bc5f-61d9-4f9e-9ce5-99c9083e2caa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208969
Listing Expiration 2026-12-31
Marketing Start 2024-05-07

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 763293669
Hyphenated Format 76329-3669

Supplemental Identifiers

RxCUI
2637879 2680741
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 rextovy (source: ndc)
Generic Name naloxone hydrochloride (source: ndc)
Application Number NDA208969 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.25mL
source: ndc
Packaging
  • 2 CONTAINER in 1 CONTAINER (76329-3669-2) / .25 mL in 1 CONTAINER
source: ndc

Packages (1)

76329-3669-2 2 CONTAINER in 1 CONTAINER (76329-3669-2) / .25 mL in 1 CONTAINER

Ingredients (1)

naloxone hydrochloride (4 mg/.25mL)

Linked Drug Pages (1)

REXTOVY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "25c8bc5f-61d9-4f9e-9ce5-99c9083e2caa", "openfda": {"unii": ["F850569PQR"], "rxcui": ["2637879", "2680741"], "spl_set_id": ["fe9735db-c57e-44a8-bffb-b87a84c2a6f3"], "manufacturer_name": ["International Medication Systems, Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CONTAINER in 1 CONTAINER (76329-3669-2)  / .25 mL in 1 CONTAINER", "package_ndc": "76329-3669-2", "marketing_start_date": "20240507"}], "brand_name": "REXTOVY", "product_id": "76329-3669_25c8bc5f-61d9-4f9e-9ce5-99c9083e2caa", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "76329-3669", "generic_name": "Naloxone Hydrochloride", "labeler_name": "International Medication Systems, Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "REXTOVY", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "4 mg/.25mL"}], "application_number": "NDA208969", "marketing_category": "NDA", "marketing_start_date": "20240507", "listing_expiration_date": "20261231"}