naloxone hydrochloride

Generic: naloxone hydrochloride

Labeler: sina health inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naloxone hydrochloride
Generic Name naloxone hydrochloride
Labeler sina health inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

naloxone hydrochloride .4 mg/mL

Manufacturer
Sina Health Inc

Identifiers & Regulatory

Product NDC 70385-2033
Product ID 70385-2033_48355744-9af7-05f7-e063-6294a90ae4a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207633
Listing Expiration 2027-12-31
Marketing Start 2017-08-08

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 703852033
Hyphenated Format 70385-2033

Supplemental Identifiers

RxCUI
1659929
UPC
0370069071014
UNII
F850569PQR

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 ANDA207633 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 PACKAGE (70385-2033-1) / 1 mL in 1 VIAL
source: ndc

Packages (1)

70385-2033-1 1 VIAL in 1 PACKAGE (70385-2033-1) / 1 mL in 1 VIAL

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": "48355744-9af7-05f7-e063-6294a90ae4a0", "openfda": {"upc": ["0370069071014"], "unii": ["F850569PQR"], "rxcui": ["1659929"], "spl_set_id": ["2879294f-9af9-459e-e063-6394a90a0820"], "manufacturer_name": ["Sina Health Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 PACKAGE (70385-2033-1)  / 1 mL in 1 VIAL", "package_ndc": "70385-2033-1", "marketing_start_date": "20170808"}], "brand_name": "Naloxone Hydrochloride", "product_id": "70385-2033_48355744-9af7-05f7-e063-6294a90ae4a0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "70385-2033", "generic_name": "Naloxone Hydrochloride", "labeler_name": "Sina Health Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naloxone Hydrochloride", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".4 mg/mL"}], "application_number": "ANDA207633", "marketing_category": "ANDA", "marketing_start_date": "20170808", "listing_expiration_date": "20271231"}