dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride in 0.9% sodium chloride

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

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride in 0.9% sodium chloride
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-297
Product ID 55150-297_72d6b6e6-236e-44f8-a747-de2ee97bca87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210321
Listing Expiration 2026-12-31
Marketing Start 2020-12-07

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 55150297
Hyphenated Format 55150-297

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 in 0.9% sodium chloride (source: ndc)
Application Number ANDA210321 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (55150-297-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
source: ndc

Packages (1)

55150-297-10 10 POUCH in 1 CARTON (55150-297-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Ingredients (1)

dexmedetomidine hydrochloride (4 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": "10 POUCH in 1 CARTON (55150-297-10)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "55150-297-10", "marketing_start_date": "20201207"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "55150-297_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": "55150-297", "generic_name": "Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "4 ug/mL"}], "application_number": "ANDA210321", "marketing_category": "ANDA", "marketing_start_date": "20201207", "listing_expiration_date": "20261231"}