Package 0407-1413-53

Brand: omnipaque

Generic: iohexol
NDC Package

Package Facts

Identity

Package NDC 0407-1413-53
Digits Only 0407141353
Product NDC 0407-1413
Description

10 BOTTLE, GLASS in 1 BOX (0407-1413-53) / 125 mL in 1 BOTTLE, GLASS

Marketing

Marketing Status
Marketed Since 1985-12-26
Brand omnipaque
Generic iohexol
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRA-ARTICULAR", "INTRATHECAL", "INTRAVASCULAR", "INTRAVENOUS", "ORAL", "RECTAL"], "spl_id": "5bd452ab-2645-4f2d-8f53-2e984ee231b4", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["4419T9MX03"], "spl_set_id": ["eee15ebe-d349-4497-acef-6abe7a8247fb"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["GE Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 BOX (0407-1413-10)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "0407-1413-10", "marketing_start_date": "19851226"}, {"sample": false, "description": "10 BOTTLE, GLASS in 1 BOX (0407-1413-53)  / 125 mL in 1 BOTTLE, GLASS", "package_ndc": "0407-1413-53", "marketing_start_date": "19851226"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-59)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-1413-59", "marketing_start_date": "19851226"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-61)  / 50 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-1413-61", "marketing_start_date": "19851226"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-63)  / 100 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-1413-63", "marketing_start_date": "19851226"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-65)  / 150 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-1413-65", "marketing_start_date": "19851226"}], "brand_name": "OMNIPAQUE", "product_id": "0407-1413_5bd452ab-2645-4f2d-8f53-2e984ee231b4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0407-1413", "generic_name": "Iohexol", "labeler_name": "GE Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OMNIPAQUE", "active_ingredients": [{"name": "IOHEXOL", "strength": "300 mg/mL"}], "application_number": "NDA018956", "marketing_category": "NDA", "marketing_start_date": "19851226", "listing_expiration_date": "20261231"}