FDA.reportPublic FDA data

OMNISCAN

Product NDC
0407-0690
11-digit product format
004070690
Labeler code
0407
Product ID
0407-0690_dfe2f58c-7a8f-408a-9690-6300a49eda17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadodiamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
GE Healthcare Inc.
Application
NDA020123
Marketing category
NDA
Marketing start
2002-04-19
Substance
GADODIAMIDE
Active strength
287 mg/mL
Pharmacologic classes
Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OMNISCAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADODIAMIDE287 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii84F6U3J2R6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0407-0690-05OMNISCAN5 mL in 1 VIALINJECTION524
0407-0690-05OMNISCAN10 in 1 BOXINJECTION1024
0407-0690-10OMNISCAN10 in 1 BOXINJECTION1024
0407-0690-10OMNISCAN10 mL in 1 VIALINJECTION1024
0407-0690-12OMNISCAN10 mL in 1 SYRINGE, PLASTICINJECTION1024
0407-0690-12OMNISCAN10 in 1 BOXINJECTION1024
0407-0690-15OMNISCAN15 mL in 1 VIALINJECTION1524
0407-0690-15OMNISCAN10 in 1 BOXINJECTION1024
0407-0690-17OMNISCAN15 mL in 1 SYRINGE, PLASTICINJECTION1524
0407-0690-17OMNISCAN10 in 1 BOXINJECTION1024
0407-0690-20OMNISCAN20 mL in 1 VIALINJECTION2024
0407-0690-20OMNISCAN10 in 1 BOXINJECTION1024
0407-0690-22OMNISCAN10 in 1 BOXINJECTION1024
0407-0690-22OMNISCAN20 mL in 1 SYRINGE, PLASTICINJECTION2024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-0690-05ML - Milliliter0407-0690e31c732f-7b06-4f54-bce2-f0921970205d12012-07-24
0407-0690-10ML - Milliliter0407-0690ebee1b25-032f-4e22-a1e7-f5186f352d1112012-07-24
0407-0690-12ML - Milliliter0407-06907524219d-cdea-4aa4-8476-ab2d47d1974a12012-07-24
0407-0690-15ML - Milliliter0407-0690f927c2da-4390-46f0-b188-eade667b8fc412012-07-24
0407-0690-17ML - Milliliter0407-0690288f75cb-8dc0-40a3-8793-618c0dff519d12012-07-24
0407-0690-20ML - Milliliter0407-0690fec52cdd-0757-4e34-a007-e026c2bdda3612012-07-24
0407-0690-22ML - Milliliter0407-069068414cf1-9fac-48a9-af13-b2278c50d3cb12012-07-24
0407-0690-30ML - Milliliter0407-0690a78db6c3-4902-49c6-a1a6-41a71c102ed112012-07-24
0407-0690-40ML - Milliliter0407-06903686026f-33e0-4686-a364-49c7c445d66b12012-07-24
0407-0690-42ML - Milliliter0407-06907571ef70-47b3-425a-a9f4-bd91a480697612012-07-24
0407-0690-43ML - Milliliter0407-06904212db65-11dc-4ea3-9d46-92d752ebbde612012-07-24
0407-0690-50ML - Milliliter0407-06902048dc46-0517-46a2-88d8-054ae5a6bb3112013-03-03
0407-0690-70ML - Milliliter0407-0690dd9ec9e4-4a4d-408c-964c-438e91a77def12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gadodiamideACTIVE INGREDIENT84F6U3J2R6OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]11
gadodiamideACTIVE MOIETY84F6U3J2R6OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]11
caldiamide sodiumINACTIVE INGREDIENT1M6415C70MOMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]11
hydrochloric acidINACTIVE INGREDIENTQTT17582CBOMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]11
sodium hydroxideINACTIVE INGREDIENT55X04QC32IOMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0407-0690OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]24Current NDC, Legacy NDC, 14 package rows20250426_1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0407-0690-050040706900510 VIAL in 1 BOX (0407-0690-05) > 5 mL in 1 VIAL10 vial2002-04-190000-00-00NoNoCurrent
0407-0690-100040706901010 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL10 vial2002-04-190000-00-00NoNoCurrent
0407-0690-120040706901210 SYRINGE, PLASTIC in 1 BOX (0407-0690-12) > 10 mL in 1 SYRINGE, PLASTIC2002-04-190000-00-00NoNoCurrent
0407-0690-150040706901510 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL10 vial2002-04-190000-00-00NoNoCurrent
0407-0690-170040706901710 SYRINGE, PLASTIC in 1 BOX (0407-0690-17) > 15 mL in 1 SYRINGE, PLASTIC2002-04-190000-00-00NoNoCurrent
0407-0690-200040706902010 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL10 vial2002-04-190000-00-00NoNoCurrent
0407-0690-220040706902210 SYRINGE, PLASTIC in 1 BOX (0407-0690-22) > 20 mL in 1 SYRINGE, PLASTIC2002-04-190000-00-00NoNoCurrent
0407-0690-300040706903010 VIAL in 1 BOX (0407-0690-30) > 10 mL in 1 VIAL10 vial2010-06-012024-05-05NoNoCurrent
0407-0690-400040706904010 VIAL in 1 BOX (0407-0690-40) > 15 mL in 1 VIAL10 vial2010-06-012024-04-10NoNoCurrent
0407-0690-420040706904210 SYRINGE in 1 BOX (0407-0690-42) > 15 mL in 1 SYRINGE10 syringe2010-06-010000-00-00NoNoCurrent
0407-0690-430040706904310 SYRINGE in 1 BOX (0407-0690-43) > 20 mL in 1 SYRINGE10 syringe2010-06-010000-00-00NoNoCurrent
0407-0690-500040706905010 VIAL in 1 BOX (0407-0690-50) > 20 mL in 1 VIAL10 vial2010-06-010000-00-00NoNoCurrent
0407-0690-700040706907010 BOTTLE, PLASTIC in 1 BOX (0407-0690-70) > 100 mL in 1 BOTTLE, PLASTIC2007-10-020000-00-00NoNoCurrent