naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: international medication systems, limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler international medication systems, limited
Dosage Form INJECTION
Routes
PARENTERAL
Active Ingredients

naloxone hydrochloride 1 mg/mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-3469
Product ID 76329-3469_2ab20a74-a067-4d43-84fb-fe331192c34b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072076
Listing Expiration 2026-12-31
Marketing Start 2016-07-28

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 763293469
Hyphenated Format 76329-3469

Supplemental Identifiers

RxCUI
1191250
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 ANDA072076 (source: ndc)
Routes
PARENTERAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 BOX (76329-3469-1) / 2 mL in 1 SYRINGE
source: ndc

Packages (1)

76329-3469-1 10 SYRINGE in 1 BOX (76329-3469-1) / 2 mL in 1 SYRINGE

Ingredients (1)

naloxone hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Naloxone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["PARENTERAL"], "spl_id": "2ab20a74-a067-4d43-84fb-fe331192c34b", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1191250"], "spl_set_id": ["d2f5bfa0-933e-46d0-8b1a-9f90e6aaba54"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 BOX (76329-3469-1)  / 2 mL in 1 SYRINGE", "package_ndc": "76329-3469-1", "marketing_start_date": "20160728"}], "brand_name": "Naloxone Hydrochloride", "product_id": "76329-3469_2ab20a74-a067-4d43-84fb-fe331192c34b", "dosage_form": "INJECTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "76329-3469", "generic_name": "Naloxone Hydrochloride", "labeler_name": "International Medication Systems, Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA072076", "marketing_category": "ANDA", "marketing_start_date": "20160728", "listing_expiration_date": "20261231"}