dexmedetomidine hydrochloride in sodium chloride

Generic: dexmedetomidine hydrochloride

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride in sodium chloride
Generic Name dexmedetomidine hydrochloride
Labeler precision dose, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-247
Product ID 68094-247_721350a6-f9ae-4c06-b8b5-41169d7cd43e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212857
Listing Expiration 2026-12-31
Marketing Start 2020-11-23

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 68094247
Hyphenated Format 68094-247

Supplemental Identifiers

RxCUI
1718900 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 in sodium chloride (source: ndc)
Generic Name dexmedetomidine hydrochloride (source: ndc)
Application Number ANDA212857 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 10 BOTTLE in 1 CARTON (68094-247-10) / 100 mL in 1 BOTTLE (68094-247-01)
source: ndc

Packages (1)

68094-247-10 10 BOTTLE in 1 CARTON (68094-247-10) / 100 mL in 1 BOTTLE (68094-247-01)

Ingredients (1)

dexmedetomidine hydrochloride (4 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine Hydrochloride in Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "721350a6-f9ae-4c06-b8b5-41169d7cd43e", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718900", "1718906", "1718909"], "spl_set_id": ["e9d5c989-ebf6-4377-9c6e-7aef848a03a1"], "manufacturer_name": ["Precision Dose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE in 1 CARTON (68094-247-10)  / 100 mL in 1 BOTTLE (68094-247-01)", "package_ndc": "68094-247-10", "marketing_start_date": "20201123"}], "brand_name": "Dexmedetomidine Hydrochloride in Sodium Chloride", "product_id": "68094-247_721350a6-f9ae-4c06-b8b5-41169d7cd43e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "68094-247", "generic_name": "Dexmedetomidine Hydrochloride", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride in Sodium Chloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "4 ug/mL"}], "application_number": "ANDA212857", "marketing_category": "ANDA", "marketing_start_date": "20201123", "listing_expiration_date": "20261231"}