optiray 350

Generic: ioversol

Labeler: liebel-flarsheim company llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name optiray 350
Generic Name ioversol
Labeler liebel-flarsheim company llc
Dosage Form INJECTION
Routes
INTRA-ARTERIAL INTRAVENOUS
Active Ingredients

ioversol 741 mg/mL

Manufacturer
Liebel-Flarsheim Company LLC

Identifiers & Regulatory

Product NDC 0019-1333
Product ID 0019-1333_471b67c4-92c2-de51-e063-6394a90ada6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020923
Listing Expiration 2026-12-31
Marketing Start 2011-10-17

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 00191333
Hyphenated Format 0019-1333

Supplemental Identifiers

UPC
0300191332615 0300191323613
UNII
N3RIB7X24K
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 optiray 350 (source: ndc)
Generic Name ioversol (source: ndc)
Application Number NDA020923 (source: ndc)
Routes
INTRA-ARTERIAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 741 mg/mL
source: ndc
Packaging
  • 12 BOTTLE, GLASS in 1 CARTON (0019-1333-51) / 250 mL in 1 BOTTLE, GLASS
  • 6 BOTTLE, GLASS in 1 CARTON (0019-1333-61) / 500 mL in 1 BOTTLE, GLASS
source: ndc

Packages (2)

0019-1333-51 12 BOTTLE, GLASS in 1 CARTON (0019-1333-51) / 250 mL in 1 BOTTLE, GLASS 0019-1333-61 6 BOTTLE, GLASS in 1 CARTON (0019-1333-61) / 500 mL in 1 BOTTLE, GLASS

Ingredients (1)

ioversol (741 mg/mL)

Linked Drug Pages (3)

Optiray 320, Optiray 300, Optiray 350 ndc-match (0.9) Optiray 320, Optiray 350 ndc-match (0.9) Optiray 320, Optiray 350 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTERIAL", "INTRAVENOUS"], "spl_id": "471b67c4-92c2-de51-e063-6394a90ada6c", "openfda": {"nui": ["N0000180185", "N0000010258"], "upc": ["0300191332615", "0300191323613"], "unii": ["N3RIB7X24K"], "spl_set_id": ["6cb6ca5f-b249-49b0-a9eb-8aa583da7c74"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["Liebel-Flarsheim Company LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BOTTLE, GLASS in 1 CARTON (0019-1333-51)  / 250 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1333-51", "marketing_start_date": "20111017"}, {"sample": false, "description": "6 BOTTLE, GLASS in 1 CARTON (0019-1333-61)  / 500 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1333-61", "marketing_start_date": "20111017"}], "brand_name": "Optiray 350", "product_id": "0019-1333_471b67c4-92c2-de51-e063-6394a90ada6c", "dosage_form": "INJECTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0019-1333", "generic_name": "Ioversol", "labeler_name": "Liebel-Flarsheim Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Optiray", "brand_name_suffix": "350", "active_ingredients": [{"name": "IOVERSOL", "strength": "741 mg/mL"}], "application_number": "NDA020923", "marketing_category": "NDA", "marketing_start_date": "20111017", "listing_expiration_date": "20261231"}