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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017057-002CYSTO-CONRAY IIIOTHALAMATE MEGLUMINE17.2%SOLUTION / INTRAVESICALApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017057-002CYSTO-CONRAY II17.2%SOLUTION / INTRAVESICALApproved before 1982cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XUW72GOP7WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8841ab4d-674d-4beb-88a5-13e35f6005ccAvailable on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cysto-Conray IIIOTHALAMATE MEGLUMINELiebel-Flarsheim Company LLC8841ab4d-674d-4beb-88a5-13e35f6005cc2020-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017057
application number: NDA017057
ndc (product): 0019-0862

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