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1. Clarograf
2. Iopromid
3. Lopromid
4. N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(2-methoxyacetamido)-n-methylisophthalamide
5. Ultravist
6. Ultravist 300
1. 73334-07-3
2. Ultravist
3. Iopromidum
4. Iopromida
5. Proscope
6. N1,n3-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(2-methoxyacetamido)-n1-methylisophthalamide
7. Zk 35760
8. 1-n,3-n-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(2-methoxyacetyl)amino]-3-n-methylbenzene-1,3-dicarboxamide
9. Zk-35760
10. Magnesium Methanide Propan-1-ide(1:1:1)
11. N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(2-methoxyacetamido)-n-methylisophthalamide
12. 712bac33mz
13. Ultravist 300
14. Chebi:63578
15. N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-n-methylisophthalamide
16. Ultravist 370
17. Iopromid
18. Dsstox_cid_3163
19. Dsstox_rid_76898
20. Dsstox_gsid_23163
21. 1,3-benzenedicarboxamide, N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-((methoxyacetyl)amino)-n-methyl-
22. Shl 414c
23. Iopromidum [inn-latin]
24. Iopromida [inn-spanish]
25. Ultravist 150
26. Ultravist 240
27. Einecs 277-385-9
28. Ultravist (pharmacy Bulk)
29. Brn 7085608
30. Unii-712bac33mz
31. Iopromide [usan:usp:inn:ban]
32. Ultravist (tn)
33. Ncgc00016923-01
34. Proscope (tn)
35. Cas-73334-07-3
36. Bay86-4877
37. Bay 86-4877
38. Iopromide [inn]
39. Iopromide [jan]
40. Iopromide [mi]
41. Iopromide [usan]
42. Prestwick0_000872
43. Prestwick1_000872
44. Prestwick2_000872
45. Prestwick3_000872
46. Iopromide [vandf]
47. Iopromide [mart.]
48. Iopromide [usp-rs]
49. Iopromide [who-dd]
50. Chembl1725
51. Iopromide (jan/usp/inn)
52. Schembl24546
53. Bspbio_000943
54. Mls002154045
55. Iopromide, Analytical Standard
56. Spbio_002864
57. Bpbio1_001039
58. Iopromide [ep Impurity]
59. Iopromide [orange Book]
60. Dtxsid0023163
61. Iopromide [ep Monograph]
62. Iopromide [usp Monograph]
63. Hms1570p05
64. Hms2097p05
65. Hms2233o23
66. Hms3370m05
67. Hms3714p05
68. Bcp08449
69. Hy-b1362
70. Tox21_110684
71. Ultravist 300 In Plastic Container
72. Ac-535
73. Mfcd00867924
74. S3207
75. Akos025402129
76. Tox21_110684_1
77. Ccg-220872
78. Db09156
79. Iopromid 100 Microg/ml In Acetonitrile
80. Ncgc00179367-01
81. Ncgc00179367-03
82. 1,3-benzenedicarboxamide, N,n'-bis(2,3-dihydroxypropyl)-5-((methoxyacetyl)amino)-n-methyl-2,4,6-triiodo-
83. Bs-17441
84. Smr001233368
85. Ab00513942
86. Cs-0013103
87. Ft-0627283
88. D01893
89. 334i073
90. Sr-01000841262
91. Q4202805
92. Sr-01000841262-2
93. Iopromide, European Pharmacopoeia (ep) Reference Standard
94. Iopromide, United States Pharmacopeia (usp) Reference Standard
95. Iopromide For System Suitability 1, European Pharmacopoeia (ep) Reference Standard
96. Iopromide For System Suitability 2, European Pharmacopoeia (ep) Reference Standard
97. 1,3-benzenedicarboxamide, N1,n3-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(2-methoxyacetyl)amino]-n1-methyl-
98. N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-n-methyl-5-{[(methyloxy)acetyl]amino}benzene-1,3-dicarboxamide
99. N-(2,3-dihydroxypropyl)-3-[(2,3-dihydroxypropyl)(methyl)carbamoyl]-5-[(1-hydroxy-2-methoxyethylidene)amino]-2,4,6-triiodobenzene-1-carboximidic Acid
| Molecular Weight | 791.1 g/mol |
|---|---|
| Molecular Formula | C18H24I3N3O8 |
| XLogP3 | -2.1 |
| Hydrogen Bond Donor Count | 6 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 11 |
| Exact Mass | 790.8698 g/mol |
| Monoisotopic Mass | 790.8698 g/mol |
| Topological Polar Surface Area | 169 Ų |
| Heavy Atom Count | 32 |
| Formal Charge | 0 |
| Complexity | 647 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 10 | |
|---|---|
| Drug Name | Ultravist |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 62.3%; 49.9%; 76.9% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
| 2 of 10 | |
|---|---|
| Drug Name | Ultravist 150 |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 31.2% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
| 3 of 10 | |
|---|---|
| Drug Name | Ultravist 240 |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 49.9% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
| 4 of 10 | |
|---|---|
| Drug Name | Ultravist 300 |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 62.3% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
| 5 of 10 | |
|---|---|
| Drug Name | Ultravist 370 |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 76.9% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
| 6 of 10 | |
|---|---|
| Drug Name | Ultravist |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 62.3%; 49.9%; 76.9% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
| 7 of 10 | |
|---|---|
| Drug Name | Ultravist 150 |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 31.2% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
| 8 of 10 | |
|---|---|
| Drug Name | Ultravist 240 |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 49.9% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
| 9 of 10 | |
|---|---|
| Drug Name | Ultravist 300 |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 62.3% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
| 10 of 10 | |
|---|---|
| Drug Name | Ultravist 370 |
| Active Ingredient | Iopromide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 76.9% |
| Market Status | Prescription |
| Company | Bayer Hlthcare |
Iopromide, as the product Iovist, is indicated for use as an X-ray contrast agent in the following procedures: Intra-arterial digital subtraction angiography (IA-DSA) (150 mg I/mL) Cerebral arteriography and peripheral arteriography (300 mg I/mL) Coronary arteriography and left ventriculography, visceral angiography and aortography (370 mg I/mL) Peripheral venography (240 mg I/mL) Excretory urography (300 mg I/mL) Contrast computed tomography (CT) imaging of head and body (300 mg I/mL and 370 mg I/mL)
FDA Label
Contrast Media
Substances used to allow enhanced visualization of tissues. (See all compounds classified as Contrast Media.)
V08AB05
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
V - Various
V08 - Contrast media
V08A - X-ray contrast media, iodinated
V08AB - Watersoluble, nephrotropic, low osmolar x-ray contrast media
V08AB05 - Iopromide
Absorption
Following administration, the degree of contrast enhancement is directly related to the iodine content in the administered dose; peak iodine plasma levels occur immediately following rapid intravenous injection. Iodine plasma levels fall rapidly within 5 to 10 minutes, which can be accounted for by the dilution in the vascular and extravascular fluid compartments. Contrast enhancement appears to be greatest immediately after bolus injections (15 seconds to 120 seconds). Thus, greatest enhancement may be detected by a series of consecutive two-to-three second scans performed within 30 to 90 seconds after injection (that is, dynamic computed tomographic imaging). Injection may be visualized in the renal parenchyma within 3060 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 13 minutes, with optimum contrast occurring within 515 minutes.
Route of Elimination
The amounts excreted unchanged in urine represent 97% of the dose in young healthy subjects. Only 2% of the dose is recovered in the feces. Similar recoveries in urine and feces are observed in middle-aged and elderly patients. This finding suggests that, compared to the renal route, biliary and/or gastrointestinal excretion is not important for iopromide. During the slower terminal phase only 3% of the dose is eliminated; 97% of the dose is disposed of during the earlier phases, the largest part of which occurs during the main elimination phase.
Volume of Distribution
16 L
Clearance
The mean total and renal clearances are 107 mL/min and 104 mL/min, respectively.
Iopromide is not metabolized.
After intravenous administration to healthy young volunteers, plasma iopromide concentration time profile shows an initial distribution phase with a half-life of 0.24 hour; a main elimination phase with a half-life of 2 hours; and a terminal elimination phase with a half-life of 6.2 hours.
Iopromide is a low osmolar, non-ionic X-ray contrast agent for intravascular administration. It functions as a contrast agent by opacifying blood vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8178
Submission : 1989-08-15
Status : Active
Type : II
Certificate Number : R0-CEP 2020-273 - Rev 00
Issue Date : 2021-01-06
Type : Chemical
Substance Number : 1753
Status : Valid
Registration Number : 221MF10003
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2009-01-13
Latest Date of Registration : --
Registrant Name : Bayer Korea Ltd.
Registration Date : 2018-07-06
Registration Number : 20180706-210-J-240
Manufacturer Name : Bayer AG
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38239
Submission : 2023-04-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35356
Submission : 2020-12-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25680
Submission : 2012-01-05
Status : Inactive
Type : II
Date of Issue : 2022-06-16
Valid Till : 2025-06-16
Written Confirmation Number : WC-0031
Address of the Firm :
Date of Issue : 2020-12-18
Valid Till : 2022-06-16
Written Confirmation Number : WC-0031A3
Address of the Firm :
Certificate Number : R1-CEP 2015-172 - Rev 00
Issue Date : 2022-01-31
Type : Chemical
Substance Number : 1753
Status : Valid
Registrant Name : Bayer Korea Ltd.
Registration Date : 2018-07-06
Registration Number : 20180706-210-J-240
Manufacturer Name : Bayer AG
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen Germany
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35356
Submission : 2020-12-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8178
Submission : 1989-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25680
Submission : 2012-01-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38239
Submission : 2023-04-09
Status : Active
Type : II
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