dexmedetomidine

Generic: dexmedetomidine

Labeler: piramal critical care inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine
Generic Name dexmedetomidine
Labeler piramal critical care inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 200 ug/2mL

Manufacturer
Piramal Critical Care Inc

Identifiers & Regulatory

Product NDC 66794-230
Product ID 66794-230_3f76a806-297b-184b-e063-6394a90a7404
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202126
Listing Expiration 2026-12-31
Marketing Start 2021-01-19

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 66794230
Hyphenated Format 66794-230

Supplemental Identifiers

RxCUI
309710
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 ANDA202126 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 ug/2mL
source: ndc
Packaging
  • 25 VIAL, GLASS in 1 CARTON (66794-230-42) / 2 mL in 1 VIAL, GLASS (66794-230-02)
source: ndc

Packages (1)

66794-230-42 25 VIAL, GLASS in 1 CARTON (66794-230-42) / 2 mL in 1 VIAL, GLASS (66794-230-02)

Ingredients (1)

dexmedetomidine hydrochloride (200 ug/2mL)

Linked Drug Pages (1)

Dexmedetomidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3f76a806-297b-184b-e063-6394a90a7404", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["b93a71ed-0f9e-1ff9-e053-2995a90a789d"], "manufacturer_name": ["Piramal Critical Care Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, GLASS in 1 CARTON (66794-230-42)  / 2 mL in 1 VIAL, GLASS (66794-230-02)", "package_ndc": "66794-230-42", "marketing_start_date": "20210119"}], "brand_name": "Dexmedetomidine", "product_id": "66794-230_3f76a806-297b-184b-e063-6394a90a7404", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "66794-230", "generic_name": "Dexmedetomidine", "labeler_name": "Piramal Critical Care Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "200 ug/2mL"}], "application_number": "ANDA202126", "marketing_category": "ANDA", "marketing_start_date": "20210119", "listing_expiration_date": "20261231"}