Package 68083-527-25
Brand: dexmedetomidine
Generic: dexmedetomidinePackage Facts
Identity
Package NDC
68083-527-25
Digits Only
6808352725
Product NDC
68083-527
Description
25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL
Marketing
Marketing Status
Brand
dexmedetomidine
Generic
dexmedetomidine
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "72a287de-a53d-464e-9294-ff59945e1e73", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["714cc0d2-8a4c-40c0-8ef0-dcfde4c46989"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL", "package_ndc": "68083-527-25", "marketing_start_date": "20210628"}], "brand_name": "Dexmedetomidine", "product_id": "68083-527_72a287de-a53d-464e-9294-ff59945e1e73", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "68083-527", "generic_name": "Dexmedetomidine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA202126", "marketing_category": "ANDA", "marketing_start_date": "20210628", "listing_expiration_date": "20271231"}