dexmedetomidine

Generic: dexmedetomidine

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine
Generic Name dexmedetomidine
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-505
Product ID 84549-505_42dab90e-68c2-bed1-e063-6294a90a4b0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204843
Listing Expiration 2026-12-31
Marketing Start 2019-01-18

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 84549505
Hyphenated Format 84549-505

Supplemental Identifiers

RxCUI
309710
UNII
1018WH7F9I

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 ANDA204843 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 2 mL in 1 VIAL, SINGLE-DOSE (84549-505-03)
source: ndc

Packages (1)

84549-505-03 2 mL in 1 VIAL, SINGLE-DOSE (84549-505-03)

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": "42dab90e-68c2-bed1-e063-6294a90a4b0c", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["42dab90e-68c1-bed1-e063-6294a90a4b0c"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL, SINGLE-DOSE (84549-505-03)", "package_ndc": "84549-505-03", "marketing_start_date": "20251010"}], "brand_name": "DEXMEDETOMIDINE", "product_id": "84549-505_42dab90e-68c2-bed1-e063-6294a90a4b0c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "84549-505", "generic_name": "DEXMEDETOMIDINE", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMEDETOMIDINE", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA204843", "marketing_category": "ANDA", "marketing_start_date": "20190118", "listing_expiration_date": "20261231"}