dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-758
Product ID 70069-758_6a1a2c33-1467-4eb0-adc6-6e21771fbf6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218112
Listing Expiration 2026-12-31
Marketing Start 2024-09-26

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 70069758
Hyphenated Format 70069-758

Supplemental Identifiers

RxCUI
1788947
UPC
0370069759011 0370069759042 0370069758045 0370069758014
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 ANDA218112 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (70069-758-04) / 4 mL in 1 VIAL
source: ndc

Packages (1)

70069-758-04 4 VIAL in 1 CARTON (70069-758-04) / 4 mL in 1 VIAL

Ingredients (1)

dexmedetomidine hydrochloride (100 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6a1a2c33-1467-4eb0-adc6-6e21771fbf6b", "openfda": {"upc": ["0370069759011", "0370069759042", "0370069758045", "0370069758014"], "unii": ["1018WH7F9I"], "rxcui": ["1788947"], "spl_set_id": ["649e777b-9b30-4f1e-9fb9-6bba57580976"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (70069-758-04)  / 4 mL in 1 VIAL", "package_ndc": "70069-758-04", "marketing_start_date": "20240926"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "70069-758_6a1a2c33-1467-4eb0-adc6-6e21771fbf6b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "70069-758", "generic_name": "Dexmedetomidine Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA218112", "marketing_category": "ANDA", "marketing_start_date": "20240926", "listing_expiration_date": "20261231"}