Cysto-Conray II

Product NDC
0019-0862
11-digit product format
000190862
Labeler code
0019
Product ID
0019-0862_ff628e06-2cb5-4714-a741-1dec04bd5602
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iothalamate meglumine
Dosage form
INJECTION
Route
URETERAL
Labeler
Liebel-Flarsheim Company LLC
Application
NDA017057
Marketing category
NDA
Marketing start
2010-10-08
Substance
IOTHALAMATE MEGLUMINE
Active strength
172 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
Cysto-Conray II
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOTHALAMATE MEGLUMINE172 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
0019-0862-50Cysto-Conray II250 mL in 1 BOTTLE, GLASSINJECTION25018
0019-0862-50Cysto-Conray II12 in 1 BOXINJECTION1218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0019-0862-07ML - Milliliter0019-08626d477efb-0ccb-4951-a478-c18eb25dfab612013-02-13
0019-0862-09ML - Milliliter0019-0862fd277ead-e13b-4f24-b37f-67380ca151e912013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IOTHALAMATE MEGLUMINEACTIVE INGREDIENTXUW72GOP7WCYSTO-CONRAY II (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]13
IOTHALAMIC ACIDACTIVE MOIETY16CHD79MIXCYSTO-CONRAY II (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]13
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFCYSTO-CONRAY II (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]13
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMINACTIVE INGREDIENT3980JIH2SWCYSTO-CONRAY II (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0019-0862CYSTO-CONRAY II (IOTHALAMATE MEGLUMINE) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]18Current NDC, Legacy NDC, 2 package rows20210110_8841ab4d-674d-4beb-88a5-13e35f6005cc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0019-0862-500001908625012 BOTTLE, GLASS in 1 BOX (0019-0862-50) / 250 mL in 1 BOTTLE, GLASS2010-10-080000-00-00NoNoCurrent