zimhi

Generic: naloxone hydrochloride

Labeler: zmi pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zimhi
Generic Name naloxone hydrochloride
Labeler zmi pharma inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride 5 mg/.5mL

Manufacturer
ZMI Pharma Inc.

Identifiers & Regulatory

Product NDC 84571-140
Product ID 84571-140_4525b96b-5ab9-b8fd-e063-6294a90aa699
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212854
Listing Expiration 2026-12-31
Marketing Start 2022-01-15

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84571140
Hyphenated Format 84571-140

Supplemental Identifiers

RxCUI
2589612 2589618
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 zimhi (source: ndc)
Generic Name naloxone hydrochloride (source: ndc)
Application Number NDA212854 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/.5mL
source: ndc
Packaging
  • 2 CASE in 1 CARTON (84571-140-02) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE
  • 1 CASE in 1 CARTON (84571-140-11) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE
source: ndc

Packages (2)

84571-140-02 2 CASE in 1 CARTON (84571-140-02) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE 84571-140-11 1 CASE in 1 CARTON (84571-140-11) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE

Ingredients (1)

naloxone hydrochloride (5 mg/.5mL)

Linked Drug Pages (1)

ZIMHI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "4525b96b-5ab9-b8fd-e063-6294a90aa699", "openfda": {"unii": ["F850569PQR"], "rxcui": ["2589612", "2589618"], "spl_set_id": ["523c0909-bff6-4010-988a-53de18b7cb3f"], "manufacturer_name": ["ZMI Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CASE in 1 CARTON (84571-140-02)  / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE", "package_ndc": "84571-140-02", "marketing_start_date": "20220115"}, {"sample": false, "description": "1 CASE in 1 CARTON (84571-140-11)  / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE", "package_ndc": "84571-140-11", "marketing_start_date": "20220115"}], "brand_name": "ZIMHI", "product_id": "84571-140_4525b96b-5ab9-b8fd-e063-6294a90aa699", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "84571-140", "generic_name": "Naloxone Hydrochloride", "labeler_name": "ZMI Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZIMHI", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "5 mg/.5mL"}], "application_number": "NDA212854", "marketing_category": "NDA", "marketing_start_date": "20220115", "listing_expiration_date": "20261231"}