FDA.reportPublic FDA data

Optiray

Product NDC
0019-1332
11-digit product format
000191332
Labeler code
0019
Product ID
0019-1332_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
636 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
300
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOVERSOL636 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
0019-1332-00Optiray300100 mL in 1 SYRINGE, PLASTICINJECTION10050
0019-1332-00Optiray30020 in 1 CARTONINJECTION2050
0019-1332-06Optiray30025 in 1 CARTONINJECTION2550
0019-1332-06Optiray30050 mL in 1 BOTTLE, GLASSINJECTION5050
0019-1332-11Optiray30012 in 1 CARTONINJECTION1250
0019-1332-11Optiray300100 mL in 1 BOTTLE, GLASSINJECTION10050
0019-1332-16Optiray300150 mL in 1 BOTTLE, GLASSINJECTION15050
0019-1332-16Optiray30012 in 1 CARTONINJECTION1250
0019-1332-21Optiray300200 mL in 1 BOTTLE, GLASSINJECTION20050
0019-1332-21Optiray30012 in 1 CARTONINJECTION1250
0019-1332-75Optiray30050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1332-75Optiray30020 in 1 CARTONINJECTION2050
0019-1332-78Optiray30020 in 1 CARTONINJECTION2050
0019-1332-78Optiray30050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1332-83Optiray300100 mL in 1 SYRINGE, PLASTICINJECTION10050
0019-1332-83Optiray30020 in 1 CARTONINJECTION2050
0019-1332-90Optiray300100 mL in 1 SYRINGE, PLASTICINJECTION10050
0019-1332-90Optiray30020 in 1 CARTONINJECTION2050
0019-1332-91Optiray30075 mL in 1 SYRINGE, PLASTICINJECTION7550
0019-1332-91Optiray30020 in 1 CARTONINJECTION2050
0019-1332-61Optiray300500 mL in 1 BOTTLE, GLASSINJECTION50039
0019-1332-61Optiray3006 in 1 CARTONINJECTION639
0019-1332-65Optiray3006 in 1 CARTONINJECTION67
0019-1332-65Optiray300500 mL in 1 BOTTLE, GLASSINJECTION5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0019-1332-06ML - Milliliter0019-1332aa0b980b-27d8-4557-b5c7-29c7fecad7fb12012-07-24
0019-1332-11ML - Milliliter0019-1332958c6acf-e238-4a33-a082-4199dd637dab12012-07-24
0019-1332-16ML - Milliliter0019-1332d621f2e7-6e1f-4d86-8d64-2d844b81f13b12012-07-24
0019-1332-21ML - Milliliter0019-13322f0942da-3dc7-4450-ba59-d0da8516d64c12012-07-24
0019-1332-61ML - Milliliter0019-1332e3e743a5-a8e2-47ad-92d6-f51d3a119ee212012-07-24
0019-1332-75ML - Milliliter0019-13327f7fe832-a199-4b59-b723-064dbc042bf012012-07-24
0019-1332-78ML - Milliliter0019-1332efb9fdcf-d230-4686-9d5e-901bb196979e12013-02-13
0019-1332-83ML - Milliliter0019-133221f25907-5a66-4622-8842-f78f11940ae512012-07-24
0019-1332-90ML - Milliliter0019-133248bafd57-1995-4547-aae8-6d939ead4e7112013-02-13

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
0019-1332OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]50Current NDC, Legacy NDC, 20 package rows20230606_549d38db-d4ed-4708-8f76-7cdaa157063f.zip
0019-1332OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]36Current NDC, Legacy NDC, 2 package rows20230615_6cb6ca5f-b249-49b0-a9eb-8aa583da7c74.zip
0019-1332OPTIRAY 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
0019-1332-000001913320020 SYRINGE, PLASTIC in 1 CARTON (0019-1332-00) / 100 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1332-060001913320625 BOTTLE, GLASS in 1 CARTON (0019-1332-06) / 50 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1332-110001913321112 BOTTLE, GLASS in 1 CARTON (0019-1332-11) / 100 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1332-160001913321612 BOTTLE, GLASS in 1 CARTON (0019-1332-16) / 150 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1332-210001913322112 BOTTLE, GLASS in 1 CARTON (0019-1332-21) / 200 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1332-61000191332616 BOTTLE, GLASS in 1 CARTON (0019-1332-61) > 500 mL in 1 BOTTLE, GLASS2011-10-170000-00-00NoNoCurrent
0019-1332-65000191332656 BOTTLE, GLASS in 1 CARTON (0019-1332-65) > 500 mL in 1 BOTTLE, GLASS2020-11-180000-00-00NoNoCurrent
0019-1332-750001913327520 SYRINGE, PLASTIC in 1 CARTON (0019-1332-75) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1332-780001913327820 SYRINGE, PLASTIC in 1 CARTON (0019-1332-78) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1332-830001913328320 SYRINGE, PLASTIC in 1 CARTON (0019-1332-83) / 100 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1332-900001913329020 SYRINGE, PLASTIC in 1 CARTON (0019-1332-90) / 100 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1332-910001913329120 SYRINGE, PLASTIC in 1 CARTON (0019-1332-91) / 75 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent