naloxone hydrochloride (70756-658)

Drug Facts

Product Profile

Brand Name naloxone hydrochloride

Generic Name naloxone hydrochloride

Labeler lifestar pharma llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS

Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer

Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-658

Product ID 70756-658_bc5568c5-97d3-49b1-94c7-f9f3c6c9d409

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA218404

Listing Expiration 2026-12-31

Marketing Start 2024-02-29

Pharmacologic Class

Classes

opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70756658

Hyphenated Format 70756-658

Supplemental Identifiers

RxCUI

1659929

UPC

0370756658825 0370756658108 0370756658252

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 ANDA218404 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS

source: ndc

Resolved Composition

Strengths

.4 mg/mL

source: ndc

Packaging

10 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-10) / 1 mL in 1 VIAL, SINGLE-DOSE
25 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-25) / 1 mL in 1 VIAL, SINGLE-DOSE
1 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-82) / 1 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (3)

70756-658-10 10 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-10) / 1 mL in 1 VIAL, SINGLE-DOSE 70756-658-25 25 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-25) / 1 mL in 1 VIAL, SINGLE-DOSE 70756-658-82 1 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-82) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "bc5568c5-97d3-49b1-94c7-f9f3c6c9d409", "openfda": {"upc": ["0370756658825", "0370756658108", "0370756658252"], "unii": ["F850569PQR"], "rxcui": ["1659929"], "spl_set_id": ["ef647e2a-84e7-4e3e-942a-b6fc250141b6"], "manufacturer_name": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-10)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70756-658-10", "marketing_start_date": "20240229"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70756-658-25", "marketing_start_date": "20240229"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-82)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70756-658-82", "marketing_start_date": "20240229"}], "brand_name": "naloxone hydrochloride", "product_id": "70756-658_bc5568c5-97d3-49b1-94c7-f9f3c6c9d409", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "70756-658", "generic_name": "naloxone hydrochloride", "labeler_name": "Lifestar Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "naloxone hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA218404", "marketing_category": "ANDA", "marketing_start_date": "20240229", "listing_expiration_date": "20261231"}