Package 84549-505-03

Brand: dexmedetomidine

Generic: dexmedetomidine
NDC Package

Package Facts

Identity

Package NDC 84549-505-03
Digits Only 8454950503
Product NDC 84549-505
Description

2 mL in 1 VIAL, SINGLE-DOSE (84549-505-03)

Marketing

Marketing Status
Marketed Since 2025-10-10
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": "42dab90e-68c2-bed1-e063-6294a90a4b0c", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["42dab90e-68c1-bed1-e063-6294a90a4b0c"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL, SINGLE-DOSE (84549-505-03)", "package_ndc": "84549-505-03", "marketing_start_date": "20251010"}], "brand_name": "DEXMEDETOMIDINE", "product_id": "84549-505_42dab90e-68c2-bed1-e063-6294a90a4b0c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "84549-505", "generic_name": "DEXMEDETOMIDINE", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMEDETOMIDINE", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA204843", "marketing_category": "ANDA", "marketing_start_date": "20190118", "listing_expiration_date": "20261231"}