Package 57664-596-50
Brand: dexmedetomidine hydrochloride
Generic: dexmedetomidine hydrochloridePackage Facts
Identity
Package NDC
57664-596-50
Digits Only
5766459650
Product NDC
57664-596
Description
25 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50) / 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40)
Marketing
Marketing Status
Brand
dexmedetomidine hydrochloride
Generic
dexmedetomidine hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "1086cd9a-8975-4c42-a120-f8b70c9a7bdb", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa"], "manufacturer_name": ["Sun Pharmaceuticals Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50) / 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40)", "package_ndc": "57664-596-50", "marketing_start_date": "20150408"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "57664-596_1086cd9a-8975-4c42-a120-f8b70c9a7bdb", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "57664-596", "generic_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "labeler_name": "Sun Pharmaceuticals Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA202126", "marketing_category": "ANDA", "marketing_start_date": "20150408", "listing_expiration_date": "20261231"}