naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6193
Product ID 0641-6193_2f3fbff5-628a-49f6-9867-06c876742876
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212300
Listing Expiration 2026-12-31
Marketing Start 2025-07-25

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416193
Hyphenated Format 0641-6193

Supplemental Identifiers

RxCUI
1191250 2679504
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 ANDA212300 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (0641-6193-10) / 1 mL in 1 SYRINGE (0641-6193-01)
source: ndc

Packages (1)

0641-6193-10 10 SYRINGE in 1 CARTON (0641-6193-10) / 1 mL in 1 SYRINGE (0641-6193-01)

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": "2f3fbff5-628a-49f6-9867-06c876742876", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1191250", "2679504"], "spl_set_id": ["e6467385-6990-498c-8a0e-f4a40ef33cb7"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (0641-6193-10)  / 1 mL in 1 SYRINGE (0641-6193-01)", "package_ndc": "0641-6193-10", "marketing_start_date": "20250831"}], "brand_name": "Naloxone Hydrochloride", "product_id": "0641-6193_2f3fbff5-628a-49f6-9867-06c876742876", "dosage_form": "INJECTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "0641-6193", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA212300", "marketing_category": "ANDA", "marketing_start_date": "20250725", "listing_expiration_date": "20261231"}