dexmedetomidine

Generic: dexmedetomidine

Labeler: avenacy inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine
Generic Name dexmedetomidine
Labeler avenacy inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Avenacy Inc.

Identifiers & Regulatory

Product NDC 83634-600
Product ID 83634-600_3e30e931-4d42-465c-9e4b-cd3137ba5fe2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209065
Listing Expiration 2026-12-31
Marketing Start 2024-03-15

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 83634600
Hyphenated Format 83634-600

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 ANDA209065 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (83634-600-02) / 2 mL in 1 VIAL (83634-600-41)
source: ndc

Packages (1)

83634-600-02 25 VIAL in 1 CARTON (83634-600-02) / 2 mL in 1 VIAL (83634-600-41)

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": "3e30e931-4d42-465c-9e4b-cd3137ba5fe2", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["eee6145b-d83f-4596-92d3-733934d8a3a4"], "manufacturer_name": ["Avenacy Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (83634-600-02)  / 2 mL in 1 VIAL (83634-600-41)", "package_ndc": "83634-600-02", "marketing_start_date": "20240315"}], "brand_name": "Dexmedetomidine", "product_id": "83634-600_3e30e931-4d42-465c-9e4b-cd3137ba5fe2", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "83634-600", "generic_name": "dexmedetomidine", "labeler_name": "Avenacy Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA209065", "marketing_category": "ANDA", "marketing_start_date": "20240315", "listing_expiration_date": "20261231"}