naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-1215
Product ID 0409-1215_2b456953-1487-4550-946e-50c01536c8ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070256
Listing Expiration 2026-12-31
Marketing Start 2005-07-12

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04091215
Hyphenated Format 0409-1215

Supplemental Identifiers

RxCUI
1191222 1659929
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 ANDA070256 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1215-21)
source: ndc

Packages (1)

0409-1215-01 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1215-21)

Ingredients (1)

naloxone hydrochloride (.4 mg/mL)

Linked Drug Pages (1)

Naloxone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "2b456953-1487-4550-946e-50c01536c8ad", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1191222", "1659929"], "spl_set_id": ["8535cc84-ad4a-4d67-8480-fb5a2e3406f8"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1215-21)", "package_ndc": "0409-1215-01", "marketing_start_date": "20050712"}], "brand_name": "Naloxone Hydrochloride", "product_id": "0409-1215_2b456953-1487-4550-946e-50c01536c8ad", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "0409-1215", "generic_name": "NALOXONE HYDROCHLORIDE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA070256", "marketing_category": "ANDA", "marketing_start_date": "20050712", "listing_expiration_date": "20261231"}