Naloxone Hydrochloride

Generic: Naloxone Hydrochloride

Labeler: Actavis Pharma, Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Naloxone Hydrochloride
Generic Name Naloxone Hydrochloride
Labeler Actavis Pharma, Inc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

NALOXONE HYDROCHLORIDE 4 mg/.1mL

Identifiers & Regulatory

Product NDC 0591-2971
Product ID 0591-2971_1ef1e344-e325-46f4-9dbd-1bec7ccf34dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209522
Marketing Start 2023-01-20
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05912971
Hyphenated Format 0591-2971

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 (0591-2971-99) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-2971-54) / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0591-2971-99 2 BLISTER PACK in 1 CARTON (0591-2971-99) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-2971-54) / .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": "1ef1e344-e325-46f4-9dbd-1bec7ccf34dd", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1725059"], "spl_set_id": ["e7f81903-ee0d-4909-8e06-f58c9e56a6fc"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0591-2971-99)  / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-2971-54)  / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0591-2971-99", "marketing_end_date": "20260228", "marketing_start_date": "20230120"}], "brand_name": "Naloxone Hydrochloride", "product_id": "0591-2971_1ef1e344-e325-46f4-9dbd-1bec7ccf34dd", "dosage_form": "SPRAY, METERED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "0591-2971", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "4 mg/.1mL"}], "application_number": "ANDA209522", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20230120"}