FDA.reportPublic FDA data

Optiray

Product NDC
0019-1333
11-digit product format
000191333
Labeler code
0019
Product ID
0019-1333_1884aaeb-c174-4df7-a710-82d2b1869ad2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ioversol
Dosage form
INJECTION
Route
INTRA-ARTERIAL; INTRAVENOUS
Labeler
Liebel-Flarsheim Company LLC
Application
NDA019710
Marketing category
NDA
Marketing start
2012-03-04
Substance
IOVERSOL
Active strength
741 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Optiray
Brand name suffix
350
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOVERSOL741 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN3RIB7X24K

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0019-1333-00Optiray35020 in 1 CARTONINJECTION2050
0019-1333-00Optiray350100 mL in 1 SYRINGE, PLASTICINJECTION10050
0019-1333-06Optiray35025 in 1 CARTONINJECTION2550
0019-1333-06Optiray35050 mL in 1 BOTTLE, GLASSINJECTION5050
0019-1333-11Optiray350100 mL in 1 BOTTLE, GLASSINJECTION10050
0019-1333-11Optiray35012 in 1 CARTONINJECTION1250
0019-1333-16Optiray35012 in 1 CARTONINJECTION1250
0019-1333-16Optiray350150 mL in 1 BOTTLE, GLASSINJECTION15050
0019-1333-21Optiray350200 mL in 1 BOTTLE, GLASSINJECTION20050
0019-1333-21Optiray35012 in 1 CARTONINJECTION1250
0019-1333-27Optiray350125 mL in 1 SYRINGE, PLASTICINJECTION12550
0019-1333-27Optiray35020 in 1 CARTONINJECTION2050
0019-1333-52Optiray35050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1333-52Optiray35020 in 1 CARTONINJECTION2050
0019-1333-55Optiray35020 in 1 CARTONINJECTION2050
0019-1333-55Optiray35050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1333-75Optiray35020 in 1 CARTONINJECTION2050
0019-1333-75Optiray35050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1333-77Optiray35020 in 1 CARTONINJECTION2050
0019-1333-77Optiray35050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1333-78Optiray35050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1333-78Optiray35020 in 1 CARTONINJECTION2050
0019-1333-81Optiray35020 in 1 CARTONINJECTION2050
0019-1333-81Optiray350125 mL in 1 SYRINGE, PLASTICINJECTION12550
0019-1333-83Optiray350100 mL in 1 SYRINGE, PLASTICINJECTION10050
0019-1333-83Optiray35020 in 1 CARTONINJECTION2050
0019-1333-85Optiray35075 mL in 1 SYRINGE, PLASTICINJECTION7550
0019-1333-85Optiray35020 in 1 CARTONINJECTION2050
0019-1333-87Optiray35020 in 1 CARTONINJECTION2050
0019-1333-87Optiray350125 mL in 1 SYRINGE, PLASTICINJECTION12550
0019-1333-90Optiray35020 in 1 CARTONINJECTION2050
0019-1333-90Optiray350100 mL in 1 SYRINGE, PLASTICINJECTION10050
0019-1333-91Optiray35075 mL in 1 SYRINGE, PLASTICINJECTION7550
0019-1333-91Optiray35020 in 1 CARTONINJECTION2050
0019-1333-95Optiray35020 in 1 CARTONINJECTION2050
0019-1333-95Optiray35075 mL in 1 SYRINGE, PLASTICINJECTION7550
0019-1333-51Optiray35012 in 1 CARTONINJECTION1239
0019-1333-51Optiray350250 mL in 1 BOTTLE, GLASSINJECTION25039
0019-1333-61Optiray350500 mL in 1 BOTTLE, GLASSINJECTION50039
0019-1333-61Optiray3506 in 1 CARTONINJECTION639
0019-1333-65Optiray3506 in 1 CARTONINJECTION67
0019-1333-65Optiray350500 mL in 1 BOTTLE, GLASSINJECTION5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0019-1333-00ML - Milliliter0019-1333792c4876-8146-458f-9532-fddaa17925fb12019-07-02
0019-1333-06ML - Milliliter0019-13330ee7fc4f-2bee-4c9c-b9eb-9a937620444012012-07-24
0019-1333-11ML - Milliliter0019-1333993389cd-5e52-4fa6-9743-7618580871f412012-07-24
0019-1333-16ML - Milliliter0019-133343696cef-4591-45e1-ad4d-dd60c8853ed412012-07-24
0019-1333-21ML - Milliliter0019-1333c54c40c4-11bb-426e-a22b-8b99dd58dce612012-07-24
0019-1333-27ML - Milliliter0019-1333de8448b4-5fad-4dbe-9fac-7b2ca6b8e0ca12019-02-13
0019-1333-41ML - Milliliter0019-1333f3dfe77b-bed7-4b6d-8a69-bb9a9e4a9f1612012-07-24
0019-1333-51ML - Milliliter0019-13331c5b80f8-3ace-4975-8cb1-5b499b01797d12012-07-24
0019-1333-52ML - Milliliter0019-133373aeda20-2b5a-41f1-8efd-a2d93cf2107f12018-01-12
0019-1333-61ML - Milliliter0019-1333e412d9e4-8f18-472f-bc7a-892077ef4be512012-07-24
0019-1333-75ML - Milliliter0019-13337993c180-64cc-4420-a4d5-cdc006724f7012012-07-24
0019-1333-77ML - Milliliter0019-1333640617b1-403a-4d27-9ea6-88c65f4d21db12012-07-24
0019-1333-78ML - Milliliter0019-133354ba3ce9-dc5a-44fe-9efe-bac6fcdb243412013-02-13
0019-1333-81ML - Milliliter0019-1333a90ed8a2-8aa6-4584-964a-41245480ebff12012-07-24
0019-1333-83ML - Milliliter0019-1333acdb913e-170a-4bfe-b6db-414b2fb5550512012-07-24
0019-1333-87ML - Milliliter0019-13333b9379d0-f90a-48d0-a570-fc76377a8b6712013-02-13
0019-1333-90ML - Milliliter0019-13335e5e6e1c-b1c7-406c-b323-304063dc7f9412013-02-13
0019-1333-91ML - Milliliter0019-1333e9a98f91-32b5-4907-aaeb-4e5893625a4812012-07-24
0019-1333-95ML - Milliliter0019-13338ed8365b-0bc8-420f-984c-3437083d567e12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IOVERSOLACTIVE INGREDIENTN3RIB7X24KOPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION OPTIRAY 240 (IOVERSOL) INJECTION [MALLINCKRODT INC.]33
IOVERSOLACTIVE MOIETYN3RIB7X24KOPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION OPTIRAY 240 (IOVERSOL) INJECTION [MALLINCKRODT INC.]33
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFOPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION OPTIRAY 240 (IOVERSOL) INJECTION [MALLINCKRODT INC.]33
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION OPTIRAY 240 (IOVERSOL) INJECTION [MALLINCKRODT INC.]33
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION OPTIRAY 240 (IOVERSOL) INJECTION [MALLINCKRODT INC.]33
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VOPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION OPTIRAY 240 (IOVERSOL) INJECTION [MALLINCKRODT INC.]33
IOVERSOLACTIVE INGREDIENTN3RIB7X24KOPTIRAY PHARMACY BULK PACKAGE - 350 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 320 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 300 (IOVERSOL) INJECTION [MALLINCKRODT INC.]22
IOVERSOLACTIVE MOIETYN3RIB7X24KOPTIRAY PHARMACY BULK PACKAGE - 350 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 320 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 300 (IOVERSOL) INJECTION [MALLINCKRODT INC.]22
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFOPTIRAY PHARMACY BULK PACKAGE - 350 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 320 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 300 (IOVERSOL) INJECTION [MALLINCKRODT INC.]22
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOPTIRAY PHARMACY BULK PACKAGE - 350 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 320 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 300 (IOVERSOL) INJECTION [MALLINCKRODT INC.]22
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOPTIRAY PHARMACY BULK PACKAGE - 350 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 320 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 300 (IOVERSOL) INJECTION [MALLINCKRODT INC.]22
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VOPTIRAY PHARMACY BULK PACKAGE - 350 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 320 (IOVERSOL) INJECTION OPTIRAY PHARMACY BULK PACKAGE - 300 (IOVERSOL) INJECTION [MALLINCKRODT INC.]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0019-1333OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]50Current NDC, Legacy NDC, 36 package rows20230606_549d38db-d4ed-4708-8f76-7cdaa157063f.zip
0019-1333OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]36Current NDC, Legacy NDC, 4 package rows20230615_6cb6ca5f-b249-49b0-a9eb-8aa583da7c74.zip
0019-1333OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]3Current NDC, Legacy NDC, 2 package rows20230615_cd718d1c-f813-4114-a50d-c744ff7eb1bf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0019-1333-000001913330020 SYRINGE, PLASTIC in 1 CARTON (0019-1333-00) / 100 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-060001913330625 BOTTLE, GLASS in 1 CARTON (0019-1333-06) / 50 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1333-110001913331112 BOTTLE, GLASS in 1 CARTON (0019-1333-11) / 100 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1333-160001913331612 BOTTLE, GLASS in 1 CARTON (0019-1333-16) / 150 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1333-210001913332112 BOTTLE, GLASS in 1 CARTON (0019-1333-21) / 200 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1333-270001913332720 SYRINGE, PLASTIC in 1 CARTON (0019-1333-27) / 125 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-510001913335112 BOTTLE, GLASS in 1 CARTON (0019-1333-51) / 250 mL in 1 BOTTLE, GLASS2011-10-170000-00-00NoNoCurrent
0019-1333-520001913335220 SYRINGE, PLASTIC in 1 CARTON (0019-1333-52) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-550001913335520 SYRINGE, PLASTIC in 1 CARTON (0019-1333-55) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-61000191333616 BOTTLE, GLASS in 1 CARTON (0019-1333-61) / 500 mL in 1 BOTTLE, GLASS2011-10-170000-00-00NoNoCurrent
0019-1333-65000191333656 BOTTLE, GLASS in 1 CARTON (0019-1333-65) / 500 mL in 1 BOTTLE, GLASS2020-11-180000-00-00NoNoCurrent
0019-1333-750001913337520 SYRINGE, PLASTIC in 1 CARTON (0019-1333-75) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-770001913337720 SYRINGE, PLASTIC in 1 CARTON (0019-1333-77) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-780001913337820 SYRINGE, PLASTIC in 1 CARTON (0019-1333-78) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-810001913338120 SYRINGE, PLASTIC in 1 CARTON (0019-1333-81) / 125 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-830001913338320 SYRINGE, PLASTIC in 1 CARTON (0019-1333-83) / 100 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-850001913338520 SYRINGE, PLASTIC in 1 CARTON (0019-1333-85) / 75 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-870001913338720 SYRINGE, PLASTIC in 1 CARTON (0019-1333-87) / 125 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-900001913339020 SYRINGE, PLASTIC in 1 CARTON (0019-1333-90) / 100 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-910001913339120 SYRINGE, PLASTIC in 1 CARTON (0019-1333-91) / 75 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1333-950001913339520 SYRINGE, PLASTIC in 1 CARTON (0019-1333-95) / 75 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent