dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

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

Drug Facts

Product Profile

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

dexmedetomidine hydrochloride 400 ug/100mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-925
Product ID 67457-925_b51a1fb0-fcee-4a76-9eaf-91c35813c242
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212571
Listing Expiration 2026-12-31
Marketing Start 2020-11-13

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 67457925
Hyphenated Format 67457-925

Supplemental Identifiers

RxCUI
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 (source: ndc)
Application Number ANDA212571 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 400 ug/100mL
source: ndc
Packaging
  • 10 BOTTLE in 1 CARTON (67457-925-10) / 100 mL in 1 BOTTLE (67457-925-00)
source: ndc

Packages (1)

67457-925-10 10 BOTTLE in 1 CARTON (67457-925-10) / 100 mL in 1 BOTTLE (67457-925-00)

Ingredients (1)

dexmedetomidine hydrochloride (400 ug/100mL)

Linked Drug Pages (1)

DEXMEDETOMIDINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b51a1fb0-fcee-4a76-9eaf-91c35813c242", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["f140de5a-f13d-46b4-a742-049c63e474f5"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE in 1 CARTON (67457-925-10)  / 100 mL in 1 BOTTLE (67457-925-00)", "package_ndc": "67457-925-10", "marketing_start_date": "20201113"}], "brand_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "product_id": "67457-925_b51a1fb0-fcee-4a76-9eaf-91c35813c242", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "67457-925", "generic_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMEDETOMIDINE HYDROCHLORIDE", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "400 ug/100mL"}], "application_number": "ANDA212571", "marketing_category": "ANDA", "marketing_start_date": "20201113", "listing_expiration_date": "20261231"}