dexmedetomidine

Generic: dexmedetomidine

Labeler: wg critical care, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine
Generic Name dexmedetomidine
Labeler wg critical care, llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
WG Critical Care, LLC

Identifiers & Regulatory

Product NDC 44567-601
Product ID 44567-601_e6fa3e27-b374-49b6-a678-a5954f5beae8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206628
Listing Expiration 2026-12-31
Marketing Start 2016-04-19

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 44567601
Hyphenated Format 44567-601

Supplemental Identifiers

RxCUI
1718906 1718909 1788947
UPC
0344567603244
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 (source: ndc)
Generic Name dexmedetomidine (source: ndc)
Application Number NDA206628 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (44567-601-04) / 10 mL in 1 VIAL
source: ndc

Packages (1)

44567-601-04 4 VIAL in 1 CARTON (44567-601-04) / 10 mL in 1 VIAL

Ingredients (1)

dexmedetomidine hydrochloride (100 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine, Dexmedetomidine in Dextrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e6fa3e27-b374-49b6-a678-a5954f5beae8", "openfda": {"upc": ["0344567603244"], "unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909", "1788947"], "spl_set_id": ["0d2710f2-ee47-4114-ab5c-8dca74cdcb8d"], "manufacturer_name": ["WG Critical Care, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (44567-601-04)  / 10 mL in 1 VIAL", "package_ndc": "44567-601-04", "marketing_start_date": "20170126"}], "brand_name": "Dexmedetomidine", "product_id": "44567-601_e6fa3e27-b374-49b6-a678-a5954f5beae8", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "44567-601", "generic_name": "Dexmedetomidine", "labeler_name": "WG Critical Care, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "NDA206628", "marketing_category": "NDA", "marketing_start_date": "20160419", "listing_expiration_date": "20261231"}