FDA.reportPublic FDA data

NDC 0019-0862-07 - Cysto-Conray II

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0019-0862
Requested NDC
0019-0862-07
Package NDCs from labels
0019-0862-50, 0019-0862-07
Manufacturer
Liebel-Flarsheim Company LLC | Justesa Imagen, S.A.U.
Effective date
2020-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cysto-Conray II - Liebel-Flarsheim Company LLC | Justesa Imagen, S.A.U.Liebel-Flarsheim Company LLC | Justesa Imagen, S.A.U.2020-12-31HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

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 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

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f50ba829-16c3-40a7-9822-8d6d00353b332024-02-29WarningsExact identifier
unii: 3980JIH2SW
Cysto-Conray IIIOTHALAMATE MEGLUMINELiebel-Flarsheim Company LLC8841ab4d-674d-4beb-88a5-13e35f6005cc2020-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA017057
ndc (package): 0019-0862-50
ndc (product): 0019-0862
spl id: ff628e06-2cb5-4714-a741-1dec04bd5602
spl set id: 8841ab4d-674d-4beb-88a5-13e35f6005cc
unii: XUW72GOP7W
FREDS SALINE TWIN PACK LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMFRED'S7d15057f-eb3b-477f-ab14-68c3c38ea9102018-12-26WarningsExact identifier
unii: 3980JIH2SW
Marcs Twin PackSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMarc Glassman Inc.66348ee5-803a-4b78-94dd-55bc9d3543c32018-07-10WarningsExact identifier
unii: 3980JIH2SW
QUALITY CHOICE SINGLE SALINE LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMAlcyon Health, LLC.eb499c7f-9c7b-4097-83a3-82aabffd6beb2017-07-12WarningsExact identifier
unii: 3980JIH2SW
Pro-Enema Single Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMPropharma Medical Suppliese53c5eda-21da-4aed-a592-315100167cc22017-06-08WarningsExact identifier
unii: 3980JIH2SW
Saline Laxative Cherry LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMDolgencorp Inc.ca3c00d9-4301-4de8-94f5-34f1bcc761ab2017-04-13WarningsExact identifier
unii: 3980JIH2SW

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.