optiray 320

Generic: ioversol

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

Drug Facts

Product Profile

Brand Name optiray 320
Generic Name ioversol
Labeler liebel-flarsheim company llc
Dosage Form INJECTION
Routes
INTRA-ARTERIAL INTRAVENOUS
Active Ingredients

ioversol 678 mg/mL

Manufacturer
Liebel-Flarsheim Company LLC

Identifiers & Regulatory

Product NDC 0019-1323
Product ID 0019-1323_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 00191323
Hyphenated Format 0019-1323

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 320 (source: ndc)
Generic Name ioversol (source: ndc)
Application Number NDA019710 (source: ndc)
Routes
INTRA-ARTERIAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 678 mg/mL
source: ndc
Packaging
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-00) / 100 mL in 1 SYRINGE, PLASTIC
  • 25 VIAL, GLASS in 1 CARTON (0019-1323-02) / 20 mL in 1 VIAL, GLASS
  • 25 VIAL, GLASS in 1 CARTON (0019-1323-04) / 30 mL in 1 VIAL, GLASS
  • 25 BOTTLE, GLASS in 1 CARTON (0019-1323-06) / 50 mL in 1 BOTTLE, GLASS
  • 12 BOTTLE, GLASS in 1 CARTON (0019-1323-11) / 100 mL in 1 BOTTLE, GLASS
  • 12 BOTTLE, GLASS in 1 CARTON (0019-1323-16) / 150 mL in 1 BOTTLE, GLASS
  • 12 BOTTLE, GLASS in 1 CARTON (0019-1323-21) / 200 mL in 1 BOTTLE, GLASS
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-27) / 125 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-52) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-55) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-70) / 30 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-73) / 30 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-75) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-77) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-78) / 50 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-81) / 125 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-83) / 100 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-85) / 75 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-87) / 125 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-90) / 100 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-91) / 75 mL in 1 SYRINGE, PLASTIC
  • 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-95) / 75 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (22)

0019-1323-00 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-00) / 100 mL in 1 SYRINGE, PLASTIC 0019-1323-02 25 VIAL, GLASS in 1 CARTON (0019-1323-02) / 20 mL in 1 VIAL, GLASS 0019-1323-04 25 VIAL, GLASS in 1 CARTON (0019-1323-04) / 30 mL in 1 VIAL, GLASS 0019-1323-06 25 BOTTLE, GLASS in 1 CARTON (0019-1323-06) / 50 mL in 1 BOTTLE, GLASS 0019-1323-11 12 BOTTLE, GLASS in 1 CARTON (0019-1323-11) / 100 mL in 1 BOTTLE, GLASS 0019-1323-16 12 BOTTLE, GLASS in 1 CARTON (0019-1323-16) / 150 mL in 1 BOTTLE, GLASS 0019-1323-21 12 BOTTLE, GLASS in 1 CARTON (0019-1323-21) / 200 mL in 1 BOTTLE, GLASS 0019-1323-27 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-27) / 125 mL in 1 SYRINGE, PLASTIC 0019-1323-52 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-52) / 50 mL in 1 SYRINGE, PLASTIC 0019-1323-55 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-55) / 50 mL in 1 SYRINGE, PLASTIC 0019-1323-70 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-70) / 30 mL in 1 SYRINGE, PLASTIC 0019-1323-73 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-73) / 30 mL in 1 SYRINGE, PLASTIC 0019-1323-75 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-75) / 50 mL in 1 SYRINGE, PLASTIC 0019-1323-77 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-77) / 50 mL in 1 SYRINGE, PLASTIC 0019-1323-78 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-78) / 50 mL in 1 SYRINGE, PLASTIC 0019-1323-81 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-81) / 125 mL in 1 SYRINGE, PLASTIC 0019-1323-83 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-83) / 100 mL in 1 SYRINGE, PLASTIC 0019-1323-85 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-85) / 75 mL in 1 SYRINGE, PLASTIC 0019-1323-87 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-87) / 125 mL in 1 SYRINGE, PLASTIC 0019-1323-90 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-90) / 100 mL in 1 SYRINGE, PLASTIC 0019-1323-91 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-91) / 75 mL in 1 SYRINGE, PLASTIC 0019-1323-95 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-95) / 75 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

ioversol (678 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 (0019-1323-00)  / 100 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-00", "marketing_start_date": "20120304"}, {"sample": false, "description": "25 VIAL, GLASS in 1 CARTON (0019-1323-02)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "0019-1323-02", "marketing_start_date": "20120304"}, {"sample": false, "description": "25 VIAL, GLASS in 1 CARTON (0019-1323-04)  / 30 mL in 1 VIAL, GLASS", "package_ndc": "0019-1323-04", "marketing_start_date": "20120304"}, {"sample": false, "description": "25 BOTTLE, GLASS in 1 CARTON (0019-1323-06)  / 50 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1323-06", "marketing_start_date": "20120304"}, {"sample": false, "description": "12 BOTTLE, GLASS in 1 CARTON (0019-1323-11)  / 100 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1323-11", "marketing_start_date": "20120304"}, {"sample": false, "description": "12 BOTTLE, GLASS in 1 CARTON (0019-1323-16)  / 150 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1323-16", "marketing_start_date": "20120304"}, {"sample": false, "description": "12 BOTTLE, GLASS in 1 CARTON (0019-1323-21)  / 200 mL in 1 BOTTLE, GLASS", "package_ndc": "0019-1323-21", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-27)  / 125 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-27", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-52)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-52", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-55)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-55", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-70)  / 30 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-70", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-73)  / 30 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-73", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-75)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-75", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-77)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-77", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-78)  / 50 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-78", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-81)  / 125 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-81", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-83)  / 100 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-83", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-85)  / 75 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-85", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-87)  / 125 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-87", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-90)  / 100 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-90", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-91)  / 75 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-91", "marketing_start_date": "20120304"}, {"sample": false, "description": "20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-95)  / 75 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0019-1323-95", "marketing_start_date": "20120304"}], "brand_name": "Optiray 320", "product_id": "0019-1323_1884aaeb-c174-4df7-a710-82d2b1869ad2", "dosage_form": "INJECTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0019-1323", "generic_name": "Ioversol", "labeler_name": "Liebel-Flarsheim Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Optiray", "brand_name_suffix": "320", "active_ingredients": [{"name": "IOVERSOL", "strength": "678 mg/mL"}], "application_number": "NDA019710", "marketing_category": "NDA", "marketing_start_date": "20120304", "listing_expiration_date": "20261231"}