naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: dr. reddy's laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler dr. reddy's laboratories, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride 1 mg/mL

Manufacturer
Dr. Reddy's Laboratories, Inc.

Identifiers & Regulatory

Product NDC 43598-750
Product ID 43598-750_f8812b1f-96ad-b0c9-94ad-bd638001086d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213209
Listing Expiration 2026-12-31
Marketing Start 2020-03-18

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598750
Hyphenated Format 43598-750

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 ANDA213209 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 BOX (43598-750-10) / 2 mL in 1 SYRINGE
  • 1 SYRINGE in 1 BOX (43598-750-11) / 2 mL in 1 SYRINGE
  • 10 SYRINGE in 1 BOX (43598-750-58) / 2 mL in 1 SYRINGE
source: ndc

Packages (3)

43598-750-10 10 SYRINGE in 1 BOX (43598-750-10) / 2 mL in 1 SYRINGE 43598-750-11 1 SYRINGE in 1 BOX (43598-750-11) / 2 mL in 1 SYRINGE 43598-750-58 10 SYRINGE in 1 BOX (43598-750-58) / 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": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "f8812b1f-96ad-b0c9-94ad-bd638001086d", "openfda": {"unii": ["F850569PQR"], "rxcui": ["1191250"], "spl_set_id": ["b1303f15-c48b-a44d-b28a-72f370094e02"], "manufacturer_name": ["Dr. Reddy's Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 BOX (43598-750-10)  / 2 mL in 1 SYRINGE", "package_ndc": "43598-750-10", "marketing_start_date": "20240910"}, {"sample": false, "description": "1 SYRINGE in 1 BOX (43598-750-11)  / 2 mL in 1 SYRINGE", "package_ndc": "43598-750-11", "marketing_start_date": "20200318"}, {"sample": false, "description": "10 SYRINGE in 1 BOX (43598-750-58)  / 2 mL in 1 SYRINGE", "package_ndc": "43598-750-58", "marketing_end_date": "20260430", "marketing_start_date": "20200318"}], "brand_name": "Naloxone Hydrochloride", "product_id": "43598-750_f8812b1f-96ad-b0c9-94ad-bd638001086d", "dosage_form": "INJECTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "43598-750", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Dr. Reddy's Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA213209", "marketing_category": "ANDA", "marketing_start_date": "20200318", "listing_expiration_date": "20261231"}