dexmedetomidine

Generic: dexmedetomidine

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine
Generic Name dexmedetomidine
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-209
Product ID 55150-209_72d6b6e6-236e-44f8-a747-de2ee97bca87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205867
Listing Expiration 2026-12-31
Marketing Start 2016-03-17

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 55150209
Hyphenated Format 55150-209

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 (source: ndc)
Generic Name dexmedetomidine (source: ndc)
Application Number ANDA205867 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (55150-209-02) / 2 mL in 1 VIAL
source: ndc

Packages (1)

55150-209-02 25 VIAL in 1 CARTON (55150-209-02) / 2 mL in 1 VIAL

Ingredients (1)

dexmedetomidine hydrochloride (100 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine, Dexmedetomidine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "72d6b6e6-236e-44f8-a747-de2ee97bca87", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710", "1718906", "1718909"], "spl_set_id": ["8c162541-986b-4b30-866c-b2631ba2c975"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (55150-209-02)  / 2 mL in 1 VIAL", "package_ndc": "55150-209-02", "marketing_start_date": "20160317"}], "brand_name": "Dexmedetomidine", "product_id": "55150-209_72d6b6e6-236e-44f8-a747-de2ee97bca87", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "55150-209", "generic_name": "Dexmedetomidine", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA205867", "marketing_category": "ANDA", "marketing_start_date": "20160317", "listing_expiration_date": "20261231"}