dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride
Labeler par health usa, llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 42023-146
Product ID 42023-146_a8946a56-56ee-4169-8fec-1c8fffaf9642
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203972
Listing Expiration 2026-12-31
Marketing Start 2014-08-19

Pharmacologic Class

Classes
adrenergic alpha2-agonists [moa] central alpha-2 adrenergic agonist [epc] general anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023146
Hyphenated Format 42023-146

Supplemental Identifiers

RxCUI
309710 1718906 1718909
UNII
1018WH7F9I

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 dexmedetomidine hydrochloride (source: ndc)
Generic Name dexmedetomidine hydrochloride (source: ndc)
Application Number ANDA203972 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (42023-146-25) / 2 mL in 1 VIAL
source: ndc

Packages (1)

42023-146-25 25 VIAL in 1 CARTON (42023-146-25) / 2 mL in 1 VIAL

Ingredients (1)

dexmedetomidine hydrochloride (100 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a8946a56-56ee-4169-8fec-1c8fffaf9642", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710", "1718906", "1718909"], "spl_set_id": ["1ee59985-4c1d-48f7-b8f9-5584c2d55e08"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (42023-146-25)  / 2 mL in 1 VIAL", "package_ndc": "42023-146-25", "marketing_start_date": "20140819"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "42023-146_a8946a56-56ee-4169-8fec-1c8fffaf9642", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "42023-146", "generic_name": "Dexmedetomidine Hydrochloride", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA203972", "marketing_category": "ANDA", "marketing_start_date": "20140819", "listing_expiration_date": "20261231"}