FDA.reportPublic FDA data

Conray

Product NDC
0019-0953
11-digit product format
000190953
Labeler code
0019
Product ID
0019-0953_0ad12048-60f9-474e-b488-cb152456977f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
iothalamate meglumine
Dosage form
INJECTION
Route
INTRAVASCULAR
Labeler
Liebel-Flarsheim Company LLC
Application
NDA013295
Marketing category
NDA
Marketing start
2003-10-14
Substance
IOTHALAMATE MEGLUMINE
Active strength
600 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
Conray
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOTHALAMATE MEGLUMINE600 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXUW72GOP7W

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
12862b73-6850-4518-8415-07dc41a94ae3Product name120140508
62094e4a-03c5-8dd0-8cc1-762d2eb27546Product name120140508
af8cbdc1-507e-d5b3-315b-c8689d8c5b83Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0019-0953-05Conray25 in 1 BOXINJECTION2520
0019-0953-05Conray50 mL in 1 VIAL, GLASSINJECTION5020
0019-0953-10Conray100 mL in 1 BOTTLE, GLASSINJECTION10020
0019-0953-10Conray12 in 1 BOXINJECTION1220
0019-0953-23Conray25 in 1 BOXINJECTION2520
0019-0953-23Conray30 mL in 1 VIAL, GLASSINJECTION3020
0019-0953-50Conray12 in 1 BOXINJECTION1220
0019-0953-50Conray150 mL in 1 BOTTLE, GLASSINJECTION15020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0019-0953-05ML - Milliliter0019-0953206f9aeb-ce67-4c96-8d48-7b3b8da13b4412017-12-14
0019-0953-09ML - Milliliter0019-09530dd7e9ac-7188-473d-a11c-d2189743ef9e12012-07-24
0019-0953-11ML - Milliliter0019-09530e2d6657-613a-473b-9806-93e94a2a0de112012-07-24
0019-0953-13ML - Milliliter0019-09533a2ee99b-4369-47e9-a4b1-eb47c51bbc2012012-07-24
0019-0953-15ML - Milliliter0019-09539985383c-3981-47c9-b030-1b846b3ce71812012-07-24
0019-0953-23ML - Milliliter0019-0953c85117c1-7455-43fe-b5f3-689ad24e227412019-02-13
0019-0953-50ML - Milliliter0019-0953c3816e24-7969-4a82-949c-184346e3956d12020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IOTHALAMATE MEGLUMINEACTIVE INGREDIENTXUW72GOP7WCONRAY (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]12
IOTHALAMIC ACIDACTIVE MOIETY16CHD79MIXCONRAY (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]12
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFCONRAY (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]12
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMINACTIVE INGREDIENT3980JIH2SWCONRAY (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0019-0953CONRAY (IOTHALAMATE MEGLUMINE) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]20Current NDC, Legacy NDC, 8 package rows20230513_1292abfc-496f-4df7-9a08-72072953e1f1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0019-0953-050001909530525 VIAL, GLASS in 1 BOX (0019-0953-05) / 50 mL in 1 VIAL, GLASS2003-10-140000-00-00NoNoCurrent
0019-0953-100001909531012 BOTTLE, GLASS in 1 BOX (0019-0953-10) / 100 mL in 1 BOTTLE, GLASS2003-10-140000-00-00NoNoCurrent
0019-0953-230001909532325 VIAL, GLASS in 1 BOX (0019-0953-23) / 30 mL in 1 VIAL, GLASS2003-10-140000-00-00NoNoCurrent
0019-0953-500001909535012 BOTTLE, GLASS in 1 BOX (0019-0953-50) / 150 mL in 1 BOTTLE, GLASS2003-10-140000-00-00NoNoCurrent