dexmedetomidine hydrochloride in 0.9% sodium chloride

Generic: dexmedetomidine hydrochloride in 0.9% sodium chloride

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

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride in 0.9% sodium chloride
Generic Name dexmedetomidine hydrochloride in 0.9% sodium chloride
Labeler sandoz inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 0781-3495
Product ID 0781-3495_fdf227d9-008e-60f8-e053-6294a90af5c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209065
Listing Expiration 2026-12-31
Marketing Start 2020-06-12

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 07813495
Hyphenated Format 0781-3495

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 0.9% sodium chloride (source: ndc)
Generic Name dexmedetomidine hydrochloride in 0.9% sodium chloride (source: ndc)
Application Number ANDA209065 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 10 BOTTLE in 1 CARTON (0781-3495-95) / 100 mL in 1 BOTTLE
source: ndc

Packages (1)

0781-3495-95 10 BOTTLE in 1 CARTON (0781-3495-95) / 100 mL in 1 BOTTLE

Ingredients (1)

dexmedetomidine hydrochloride (4 ug/mL)

Linked Drug Pages (1)

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fdf227d9-008e-60f8-e053-6294a90af5c4", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718900", "1718906", "1718909"], "spl_set_id": ["809e8f77-390f-4cc8-8c8a-4f67a249c9df"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE in 1 CARTON (0781-3495-95)  / 100 mL in 1 BOTTLE", "package_ndc": "0781-3495-95", "marketing_start_date": "20200612"}], "brand_name": "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE", "product_id": "0781-3495_fdf227d9-008e-60f8-e053-6294a90af5c4", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "0781-3495", "generic_name": "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "4 ug/mL"}], "application_number": "ANDA209065", "marketing_category": "ANDA", "marketing_start_date": "20200612", "listing_expiration_date": "20261231"}