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_1884aaeb-c174-4df7-a710-82d2b1869ad2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019710
Listing Expiration 2026-12-31
Marketing Start 2012-03-04

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
0300191323521 0300191333957 0300191333872 0300191323958 0300191333902 0300191323873 0300191333780 0300191323903
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 NDA019710 (source: ndc)
Routes
INTRA-ARTERIAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 741 mg/mL
source: ndc
Packaging
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-00) / 100 mL in 1 SYRINGE, PLASTIC
  • 25 BOTTLE, GLASS in 1 CARTON (0019-1333-06) / 50 mL in 1 BOTTLE, GLASS
  • 12 BOTTLE, GLASS in 1 CARTON (0019-1333-11) / 100 mL in 1 BOTTLE, GLASS
  • 12 BOTTLE, GLASS in 1 CARTON (0019-1333-16) / 150 mL in 1 BOTTLE, GLASS
  • 12 BOTTLE, GLASS in 1 CARTON (0019-1333-21) / 200 mL in 1 BOTTLE, GLASS
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-27) / 125 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-52) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-55) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-75) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-77) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-78) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-81) / 125 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-83) / 100 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-85) / 75 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-87) / 125 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-90) / 100 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-91) / 75 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-95) / 75 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (18)

0019-1333-00 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-00) / 100 mL in 1 SYRINGE, PLASTIC 0019-1333-06 25 BOTTLE, GLASS in 1 CARTON (0019-1333-06) / 50 mL in 1 BOTTLE, GLASS 0019-1333-11 12 BOTTLE, GLASS in 1 CARTON (0019-1333-11) / 100 mL in 1 BOTTLE, GLASS 0019-1333-16 12 BOTTLE, GLASS in 1 CARTON (0019-1333-16) / 150 mL in 1 BOTTLE, GLASS 0019-1333-21 12 BOTTLE, GLASS in 1 CARTON (0019-1333-21) / 200 mL in 1 BOTTLE, GLASS 0019-1333-27 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-27) / 125 mL in 1 SYRINGE, PLASTIC 0019-1333-52 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-52) / 50 mL in 1 SYRINGE, PLASTIC 0019-1333-55 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-55) / 50 mL in 1 SYRINGE, PLASTIC 0019-1333-75 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-75) / 50 mL in 1 SYRINGE, PLASTIC 0019-1333-77 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-77) / 50 mL in 1 SYRINGE, PLASTIC 0019-1333-78 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-78) / 50 mL in 1 SYRINGE, PLASTIC 0019-1333-81 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-81) / 125 mL in 1 SYRINGE, PLASTIC 0019-1333-83 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-83) / 100 mL in 1 SYRINGE, PLASTIC 0019-1333-85 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-85) / 75 mL in 1 SYRINGE, PLASTIC 0019-1333-87 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-87) / 125 mL in 1 SYRINGE, PLASTIC 0019-1333-90 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-90) / 100 mL in 1 SYRINGE, PLASTIC 0019-1333-91 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-91) / 75 mL in 1 SYRINGE, PLASTIC 0019-1333-95 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-95) / 75 mL in 1 SYRINGE, PLASTIC

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": "1884aaeb-c174-4df7-a710-82d2b1869ad2", "openfda": {"nui": ["N0000180185", "N0000010258"], "upc": ["0300191323521", "0300191333957", "0300191333872", "0300191323958", "0300191333902", "0300191323873", "0300191333780", "0300191323903"], "unii": ["N3RIB7X24K"], "spl_set_id": ["549d38db-d4ed-4708-8f76-7cdaa157063f"], "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": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-00)  / 100 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-00", "marketing_start_date": "20120304"}, {"sample": false, "description": "25 BOTTLE, GLASS in 1 CARTON (0019-1333-06)  / 50 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1333-06", "marketing_start_date": "20120304"}, {"sample": false, "description": "12 BOTTLE, GLASS in 1 CARTON (0019-1333-11)  / 100 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1333-11", "marketing_start_date": "20120304"}, {"sample": false, "description": "12 BOTTLE, GLASS in 1 CARTON (0019-1333-16)  / 150 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1333-16", "marketing_start_date": "20120304"}, {"sample": false, "description": "12 BOTTLE, GLASS in 1 CARTON (0019-1333-21)  / 200 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1333-21", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-27)  / 125 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-27", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-52)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-52", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-55)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-55", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-75)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-75", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-77)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-77", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-78)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-78", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-81)  / 125 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-81", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-83)  / 100 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-83", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-85)  / 75 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-85", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-87)  / 125 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-87", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-90)  / 100 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-90", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-91)  / 75 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-91", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-95)  / 75 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1333-95", "marketing_start_date": "20120304"}], "brand_name": "Optiray 350", "product_id": "0019-1333_1884aaeb-c174-4df7-a710-82d2b1869ad2", "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": "NDA019710", "marketing_category": "NDA", "marketing_start_date": "20120304", "listing_expiration_date": "20261231"}