Package 68083-657-10

Brand: dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 68083-657-10
Digits Only 6808365710
Product NDC 68083-657
Product ID 68083-657_e2ace91b-c8f3-444a-8353-2a4e312ff9df
Description

10 POUCH in 1 CARTON (68083-657-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Marketing

Marketing Status
Marketed Since 2024-12-19
Brand dexmedetomidine hydrochloride
Generic dexmedetomidine hydrochloride
Sample Package No

Linked Drug Pages (1)

Dexmedetomidine Hydrochloride ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e2ace91b-c8f3-444a-8353-2a4e312ff9df", "openfda": {"upc": ["0368083239015"], "unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["f307de7e-a9ab-4734-abb7-66b4e112bc51"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (68083-657-10)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "68083-657-10", "marketing_start_date": "20241219"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "68083-657_e2ace91b-c8f3-444a-8353-2a4e312ff9df", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "68083-657", "generic_name": "Dexmedetomidine Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "4 ug/mL"}], "application_number": "ANDA209307", "marketing_category": "ANDA", "marketing_start_date": "20241219", "listing_expiration_date": "20271231"}