Package 0781-3495-95

Brand: dexmedetomidine hydrochloride in 0.9% sodium chloride

Generic: dexmedetomidine hydrochloride in 0.9% sodium chloride
NDC Package

Package Facts

Identity

Package NDC 0781-3495-95
Digits Only 0781349595
Product NDC 0781-3495
Description

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

Marketing

Marketing Status
Marketed Since 2020-06-12
Brand dexmedetomidine hydrochloride in 0.9% sodium chloride
Generic dexmedetomidine hydrochloride in 0.9% sodium chloride
Sample Package No

Linked Drug Pages (1)

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"}