ultravist

Generic: iopromide

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ultravist
Generic Name iopromide
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRA-ARTERIAL INTRAVENOUS
Active Ingredients

iopromide 370 mg/mL

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-348
Product ID 50419-348_4314fa34-edbc-44f3-b40b-277c6fbd2ab0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020220
Listing Expiration 2027-12-31
Marketing Start 2022-06-08

Pharmacologic Class

Established (EPC)
radiographic contrast agent [epc]
Mechanism of Action
x-ray contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419348
Hyphenated Format 50419-348

Supplemental Identifiers

UPC
0350419344654
UNII
712BAC33MZ
NUI
N0000180185 N0000010258

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ultravist (source: ndc)
Generic Name iopromide (source: ndc)
Application Number NDA020220 (source: ndc)
Routes
INTRA-ARTERIAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 370 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (50419-348-05) / 50 mL in 1 VIAL, GLASS
  • 100 mL in 1 VIAL, GLASS (50419-348-10)
  • 100 mL in 1 VIAL, GLASS (50419-348-11)
  • 10 VIAL, GLASS in 1 CARTON (50419-348-12) / 100 mL in 1 VIAL, GLASS
  • 10 VIAL, GLASS in 1 CARTON (50419-348-13) / 100 mL in 1 VIAL, GLASS
  • 200 mL in 1 VIAL, GLASS (50419-348-20)
  • 10 VIAL, GLASS in 1 CARTON (50419-348-21) / 200 mL in 1 VIAL, GLASS
source: ndc

Packages (7)

50419-348-05 10 VIAL, GLASS in 1 CARTON (50419-348-05) / 50 mL in 1 VIAL, GLASS 50419-348-10 100 mL in 1 VIAL, GLASS (50419-348-10) 50419-348-11 100 mL in 1 VIAL, GLASS (50419-348-11) 50419-348-12 10 VIAL, GLASS in 1 CARTON (50419-348-12) / 100 mL in 1 VIAL, GLASS 50419-348-13 10 VIAL, GLASS in 1 CARTON (50419-348-13) / 100 mL in 1 VIAL, GLASS 50419-348-20 200 mL in 1 VIAL, GLASS (50419-348-20) 50419-348-21 10 VIAL, GLASS in 1 CARTON (50419-348-21) / 200 mL in 1 VIAL, GLASS

Ingredients (1)

iopromide (370 mg/mL)

Linked Drug Pages (1)

Ultravist ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTERIAL", "INTRAVENOUS"], "spl_id": "4314fa34-edbc-44f3-b40b-277c6fbd2ab0", "openfda": {"nui": ["N0000180185", "N0000010258"], "upc": ["0350419344654"], "unii": ["712BAC33MZ"], "spl_set_id": ["df917c3a-59a2-4ed1-8470-8a5394c73325"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (50419-348-05)  / 50 mL in 1 VIAL, GLASS", "package_ndc": "50419-348-05", "marketing_start_date": "20220608"}, {"sample": false, "description": "100 mL in 1 VIAL, GLASS (50419-348-10)", "package_ndc": "50419-348-10", "marketing_start_date": "20220608"}, {"sample": false, "description": "100 mL in 1 VIAL, GLASS (50419-348-11)", "package_ndc": "50419-348-11", "marketing_start_date": "20220608"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (50419-348-12)  / 100 mL in 1 VIAL, GLASS", "package_ndc": "50419-348-12", "marketing_start_date": "20220608"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (50419-348-13)  / 100 mL in 1 VIAL, GLASS", "package_ndc": "50419-348-13", "marketing_start_date": "20220608"}, {"sample": false, "description": "200 mL in 1 VIAL, GLASS (50419-348-20)", "package_ndc": "50419-348-20", "marketing_start_date": "20220608"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (50419-348-21)  / 200 mL in 1 VIAL, GLASS", "package_ndc": "50419-348-21", "marketing_start_date": "20220608"}], "brand_name": "Ultravist", "product_id": "50419-348_4314fa34-edbc-44f3-b40b-277c6fbd2ab0", "dosage_form": "INJECTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "50419-348", "generic_name": "iopromide", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ultravist", "active_ingredients": [{"name": "IOPROMIDE", "strength": "370 mg/mL"}], "application_number": "NDA020220", "marketing_category": "NDA", "marketing_start_date": "20220608", "listing_expiration_date": "20271231"}