naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler teva pharmaceuticals, inc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

naloxone hydrochloride 4 mg/.1mL

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3478
Product ID 0480-3478_7545d296-ad3c-4be1-9913-73b4f870e90c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209522
Listing Expiration 2026-12-31
Marketing Start 2024-09-23

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803478
Hyphenated Format 0480-3478

Supplemental Identifiers

RxCUI
1725059
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 ANDA209522 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/.1mL
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0480-3478-68 2 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .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": "7545d296-ad3c-4be1-9913-73b4f870e90c", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["3a73ee4b-c2a4-496f-be90-9f78c8046062"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0480-3478-68)  / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19)  / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0480-3478-68", "marketing_start_date": "20240923"}], "brand_name": "Naloxone Hydrochloride", "product_id": "0480-3478_7545d296-ad3c-4be1-9913-73b4f870e90c", "dosage_form": "SPRAY, METERED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "0480-3478", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "4 mg/.1mL"}], "application_number": "ANDA209522", "marketing_category": "ANDA", "marketing_start_date": "20240923", "listing_expiration_date": "20261231"}