FDA.reportPublic FDA data

Optiray

Product NDC
0019-1323
11-digit product format
000191323
Labeler code
0019
Product ID
0019-1323_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
678 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
320
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOVERSOL678 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
0019-1323-00Optiray320100 mL in 1 SYRINGE, PLASTICINJECTION10050
0019-1323-00Optiray32020 in 1 CARTONINJECTION2050
0019-1323-02Optiray32020 mL in 1 VIAL, GLASSINJECTION2050
0019-1323-02Optiray32025 in 1 CARTONINJECTION2550
0019-1323-04Optiray32030 mL in 1 VIAL, GLASSINJECTION3050
0019-1323-04Optiray32025 in 1 CARTONINJECTION2550
0019-1323-06Optiray32050 mL in 1 BOTTLE, GLASSINJECTION5050
0019-1323-06Optiray32025 in 1 CARTONINJECTION2550
0019-1323-11Optiray320100 mL in 1 BOTTLE, GLASSINJECTION10050
0019-1323-11Optiray32012 in 1 CARTONINJECTION1250
0019-1323-16Optiray32012 in 1 CARTONINJECTION1250
0019-1323-16Optiray320150 mL in 1 BOTTLE, GLASSINJECTION15050
0019-1323-21Optiray320200 mL in 1 BOTTLE, GLASSINJECTION20050
0019-1323-21Optiray32012 in 1 CARTONINJECTION1250
0019-1323-27Optiray32020 in 1 CARTONINJECTION2050
0019-1323-27Optiray320125 mL in 1 SYRINGE, PLASTICINJECTION12550
0019-1323-52Optiray32020 in 1 CARTONINJECTION2050
0019-1323-52Optiray32050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1323-55Optiray32050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1323-55Optiray32020 in 1 CARTONINJECTION2050
0019-1323-70Optiray32020 in 1 CARTONINJECTION2050
0019-1323-70Optiray32030 mL in 1 SYRINGE, PLASTICINJECTION3050
0019-1323-73Optiray32030 mL in 1 SYRINGE, PLASTICINJECTION3050
0019-1323-73Optiray32020 in 1 CARTONINJECTION2050
0019-1323-75Optiray32020 in 1 CARTONINJECTION2050
0019-1323-75Optiray32050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1323-77Optiray32050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1323-77Optiray32020 in 1 CARTONINJECTION2050
0019-1323-78Optiray32050 mL in 1 SYRINGE, PLASTICINJECTION5050
0019-1323-78Optiray32020 in 1 CARTONINJECTION2050
0019-1323-81Optiray320125 mL in 1 SYRINGE, PLASTICINJECTION12550
0019-1323-81Optiray32020 in 1 CARTONINJECTION2050
0019-1323-83Optiray320100 mL in 1 SYRINGE, PLASTICINJECTION10050
0019-1323-83Optiray32020 in 1 CARTONINJECTION2050
0019-1323-85Optiray32020 in 1 CARTONINJECTION2050
0019-1323-85Optiray32075 mL in 1 SYRINGE, PLASTICINJECTION7550
0019-1323-87Optiray32020 in 1 CARTONINJECTION2050
0019-1323-87Optiray320125 mL in 1 SYRINGE, PLASTICINJECTION12550
0019-1323-90Optiray320100 mL in 1 SYRINGE, PLASTICINJECTION10050
0019-1323-90Optiray32020 in 1 CARTONINJECTION2050
0019-1323-91Optiray32075 mL in 1 SYRINGE, PLASTICINJECTION7550
0019-1323-91Optiray32020 in 1 CARTONINJECTION2050
0019-1323-95Optiray32075 mL in 1 SYRINGE, PLASTICINJECTION7550
0019-1323-95Optiray32020 in 1 CARTONINJECTION2050
0019-1323-61Optiray320500 mL in 1 BOTTLE, GLASSINJECTION50039
0019-1323-61Optiray3206 in 1 CARTONINJECTION639
0019-1323-65Optiray320500 mL in 1 BOTTLE, GLASSINJECTION5007
0019-1323-65Optiray3206 in 1 CARTONINJECTION67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0019-1323-00ML - Milliliter0019-1323a5928826-3305-429a-9f2b-a2b17f4a7cb212019-02-13
0019-1323-02ML - Milliliter0019-1323f8b2f782-6cf0-409b-b5a3-0d991f02f08c12012-07-24
0019-1323-04ML - Milliliter0019-1323e7394f3c-c294-42c7-9d96-af27eeff05ba12012-07-24
0019-1323-06ML - Milliliter0019-132322544809-6e2e-4d33-86d7-ed7dc61e263d12012-07-24
0019-1323-11ML - Milliliter0019-1323c8c0c1e2-cb30-49e1-b5a5-2b50f1322dad12012-07-24
0019-1323-16ML - Milliliter0019-13230d21158d-23fb-44e7-86b0-f8202403d5f212012-07-24
0019-1323-21ML - Milliliter0019-132397386278-90c3-452b-b481-b04ecabc135a12012-07-24
0019-1323-27ML - Milliliter0019-1323e5826258-8b9a-41f2-8c5f-bfdeee921a1d12019-07-02
0019-1323-41ML - Milliliter0019-132374249ff7-e5f4-41df-91ef-e52d4fc0ead112012-07-24
0019-1323-52ML - Milliliter0019-13233bf1531b-2ff2-4096-9088-765aaae5d54f12013-02-13
0019-1323-61ML - Milliliter0019-13230cbdfdb8-ff04-4414-aa9b-0cfc3cc2d57612019-02-13
0019-1323-70ML - Milliliter0019-1323770a93bb-a22e-42ec-969b-2d5e1173d28212013-02-13
0019-1323-73ML - Milliliter0019-13235dd5523c-ca5a-4e7a-b07e-d2251e72ca7b12012-07-24
0019-1323-75ML - Milliliter0019-1323f5147cce-8454-4876-a58a-d0a7a8d51a1112012-07-24
0019-1323-77ML - Milliliter0019-1323023fa681-b9b6-46ba-b944-262f593eee8312012-07-24
0019-1323-78ML - Milliliter0019-13231ec28085-fcce-4fa2-9a85-a7f61036603212013-02-13
0019-1323-81ML - Milliliter0019-1323c67fd42a-cc78-4bde-917d-2ecb0ea8463412012-07-24
0019-1323-83ML - Milliliter0019-1323e2d4ed2d-8f93-4eff-b3de-faff42cbb46412012-07-24
0019-1323-85ML - Milliliter0019-13239e7b9795-9b2c-4064-9eaa-e59281e20a5912020-02-13
0019-1323-87ML - Milliliter0019-13231c22f313-9df7-4c78-8d5e-8442e7c12e3512013-02-13
0019-1323-90ML - Milliliter0019-13233a2cc9a2-5f40-43dd-b5e1-29008df8303612013-02-13
0019-1323-91ML - Milliliter0019-1323574dc2bc-14a5-4952-aae5-a5f17a58fc4212012-07-24
0019-1323-95ML - Milliliter0019-1323b4ff08ae-ff61-48fb-a8a2-aa308a74019e12013-02-13

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
0019-1323OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]50Current NDC, Legacy NDC, 44 package rows20230606_549d38db-d4ed-4708-8f76-7cdaa157063f.zip
0019-1323OPTIRAY 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
0019-1323OPTIRAY 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
0019-1323-000001913230020 SYRINGE, PLASTIC in 1 CARTON (0019-1323-00) / 100 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-020001913230225 VIAL, GLASS in 1 CARTON (0019-1323-02) / 20 mL in 1 VIAL, GLASS2012-03-040000-00-00NoNoCurrent
0019-1323-040001913230425 VIAL, GLASS in 1 CARTON (0019-1323-04) / 30 mL in 1 VIAL, GLASS2012-03-040000-00-00NoNoCurrent
0019-1323-060001913230625 BOTTLE, GLASS in 1 CARTON (0019-1323-06) / 50 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1323-110001913231112 BOTTLE, GLASS in 1 CARTON (0019-1323-11) / 100 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1323-160001913231612 BOTTLE, GLASS in 1 CARTON (0019-1323-16) / 150 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1323-210001913232112 BOTTLE, GLASS in 1 CARTON (0019-1323-21) / 200 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent
0019-1323-270001913232720 SYRINGE, PLASTIC in 1 CARTON (0019-1323-27) / 125 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-520001913235220 SYRINGE, PLASTIC in 1 CARTON (0019-1323-52) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-550001913235520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-55) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-61000191323616 BOTTLE, GLASS in 1 CARTON (0019-1323-61) / 500 mL in 1 BOTTLE, GLASS2011-10-170000-00-00NoNoCurrent
0019-1323-65000191323656 BOTTLE, GLASS in 1 CARTON (0019-1323-65) / 500 mL in 1 BOTTLE, GLASS2020-11-180000-00-00NoNoCurrent
0019-1323-700001913237020 SYRINGE, PLASTIC in 1 CARTON (0019-1323-70) / 30 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-730001913237320 SYRINGE, PLASTIC in 1 CARTON (0019-1323-73) / 30 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-750001913237520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-75) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-770001913237720 SYRINGE, PLASTIC in 1 CARTON (0019-1323-77) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-780001913237820 SYRINGE, PLASTIC in 1 CARTON (0019-1323-78) / 50 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-810001913238120 SYRINGE, PLASTIC in 1 CARTON (0019-1323-81) / 125 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-830001913238320 SYRINGE, PLASTIC in 1 CARTON (0019-1323-83) / 100 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-850001913238520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-85) / 75 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-870001913238720 SYRINGE, PLASTIC in 1 CARTON (0019-1323-87) / 125 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-900001913239020 SYRINGE, PLASTIC in 1 CARTON (0019-1323-90) / 100 mL in 1 SYRINGE, PLASTIC2012-03-040000-00-00NoNoCurrent
0019-1323-910001913239120 SYRINGE, PLASTIC in 1 CARTON (0019-1323-91) / 75 mL in 1 SYRINGE, PLASTIC2012-03-04NoNoCurrent
0019-1323-950001913239520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-95) / 75 mL in 1 SYRINGE, PLASTIC2012-03-04NoNoCurrent