dexmedetomidine

Generic: dexmedetomidine

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine
Generic Name dexmedetomidine
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-251
Product ID 67457-251_7c66a6ac-0548-4555-b9d1-077feb277c37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202881
Listing Expiration 2026-12-31
Marketing Start 2014-08-18

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 67457251
Hyphenated Format 67457-251

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 ANDA202881 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL, GLASS in 1 CARTON (67457-251-02) / 2 mL in 1 VIAL, GLASS (67457-251-00)
source: ndc

Packages (1)

67457-251-02 25 VIAL, GLASS in 1 CARTON (67457-251-02) / 2 mL in 1 VIAL, GLASS (67457-251-00)

Ingredients (1)

dexmedetomidine hydrochloride (100 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7c66a6ac-0548-4555-b9d1-077feb277c37", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["ebdfe2e8-30ca-4f18-935a-41bcbbce4937"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, GLASS in 1 CARTON (67457-251-02)  / 2 mL in 1 VIAL, GLASS (67457-251-00)", "package_ndc": "67457-251-02", "marketing_start_date": "20140818"}], "brand_name": "Dexmedetomidine", "product_id": "67457-251_7c66a6ac-0548-4555-b9d1-077feb277c37", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "67457-251", "generic_name": "dexmedetomidine", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA202881", "marketing_category": "ANDA", "marketing_start_date": "20140818", "listing_expiration_date": "20261231"}