naloxone hydrochloride

Generic: nalxone hydrochloride

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

Drug Facts

Product Profile

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

naloxone hydrochloride .4 mg/mL

Manufacturer
Civica, Inc.

Identifiers & Regulatory

Product NDC 72572-450
Product ID 72572-450_9d4007b7-f036-40c2-bbbe-0176fc62f249
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070299
Listing Expiration 2026-12-31
Marketing Start 2019-11-11

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72572450
Hyphenated Format 72572-450

Supplemental Identifiers

RxCUI
1191222
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 nalxone hydrochloride (source: ndc)
Application Number ANDA070299 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (72572-450-25) / 1 mL in 1 VIAL (72572-450-01)
source: ndc

Packages (1)

72572-450-25 25 VIAL in 1 CARTON (72572-450-25) / 1 mL in 1 VIAL (72572-450-01)

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": "9d4007b7-f036-40c2-bbbe-0176fc62f249", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1191222"], "spl_set_id": ["21d20dff-6efe-481e-a5a0-9c80ded73ca9"], "manufacturer_name": ["Civica, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (72572-450-25)  / 1 mL in 1 VIAL (72572-450-01)", "package_ndc": "72572-450-25", "marketing_start_date": "20191111"}], "brand_name": "Naloxone Hydrochloride", "product_id": "72572-450_9d4007b7-f036-40c2-bbbe-0176fc62f249", "dosage_form": "INJECTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "72572-450", "generic_name": "Nalxone Hydrochloride", "labeler_name": "Civica, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA070299", "marketing_category": "ANDA", "marketing_start_date": "20191111", "listing_expiration_date": "20261231"}