FDA.reportPublic FDA data

ProHance

Product NDC
0270-1111
11-digit product format
002701111
Labeler code
0270
Product ID
0270-1111_2124d0de-8f96-6f0d-6c42-7296def2661f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadoteridol
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
BRACCO DIAGNOSTICS INC
Application
NDA020131
Marketing category
NDA
Marketing start
1992-11-16
Substance
GADOTERIDOL
Active strength
279.3 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
ProHance
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOTERIDOL279.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0199MV609F

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
310ea0a0-696d-16b8-2ba5-caf071dc63f9Product name220251120
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
63824380-0c95-43c9-abef-b7f6abfb9c23Product name120211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0270-1111-70ProHance50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION5028
0270-1111-70ProHance5 in 1 BOXINJECTION, SOLUTION528
0270-1111-85ProHance5 in 1 BOXINJECTION, SOLUTION528
0270-1111-85ProHance100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION10028
0270-1111-01ProHance5 in 1 BOXINJECTION, SOLUTION524
0270-1111-01ProHance10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1024
0270-1111-02ProHance15 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1524
0270-1111-02ProHance5 in 1 BOXINJECTION, SOLUTION524
0270-1111-03ProHance5 in 1 BOXINJECTION, SOLUTION524
0270-1111-03ProHance20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2024
0270-1111-04ProHance5 in 1 BOXINJECTION, SOLUTION524
0270-1111-04ProHance5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION524

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0270-1111-01ML - Milliliter0270-1111b81221f6-0be2-4e7c-bff3-67a708733d8412012-07-24
0270-1111-02ML - Milliliter0270-11113f535d43-70e3-452c-8ad1-9a8ab235fdaa12012-07-24
0270-1111-03ML - Milliliter0270-1111587f3ccd-ea66-4641-98f3-62412825fe2212012-07-24
0270-1111-04ML - Milliliter0270-1111fff9fa11-941f-4485-9e03-466a8f4a4f2312012-07-24
0270-1111-16ML - Milliliter0270-1111b2ea1f60-110a-4a95-8f5b-bdae244c4e9c12012-07-24
0270-1111-45ML - Milliliter0270-1111ed36247b-20fd-45eb-9af7-e920576656bb12012-07-24
0270-1111-70ML - Milliliter0270-1111b60d50c7-2c56-40c3-883b-bc3baf41f56512012-07-24
0270-1111-85ML - Milliliter0270-11113d9f7836-6b15-4d0e-b429-aede493ca09212023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gadoteridolACTIVE INGREDIENT0199MV609FPROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]7
gadoteridolACTIVE MOIETY0199MV609FPROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]7
calteridol calciumINACTIVE INGREDIENTRPH56VWA1APROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]7
tromethamineINACTIVE INGREDIENT023C2WHX2VPROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]7
gadoteridolACTIVE INGREDIENT0199MV609FPROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]6
gadoteridolACTIVE MOIETY0199MV609FPROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]6
calteridol calciumINACTIVE INGREDIENTRPH56VWA1APROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]6
tromethamineINACTIVE INGREDIENT023C2WHX2VPROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0270-1111PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]28Current NDC, Legacy NDC, 4 package rows20250321_e8b76200-c0aa-491b-aad7-e22d2f68496f.zip
0270-1111PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]24Current NDC, Legacy NDC, 8 package rows20250321_778aee03-7d4c-481a-be8a-a75db0702f5a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0270-1111-01002701111015 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) / 10 mL in 1 VIAL, SINGLE-DOSE1992-11-160000-00-00NoNoCurrent
0270-1111-02002701111025 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) / 15 mL in 1 VIAL, SINGLE-DOSE1992-11-160000-00-00NoNoCurrent
0270-1111-03002701111035 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-03) / 20 mL in 1 VIAL, SINGLE-DOSE1992-11-160000-00-00NoNoCurrent
0270-1111-04002701111045 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-04) / 5 mL in 1 VIAL, SINGLE-DOSE1992-11-160000-00-00NoNoCurrent
0270-1111-16002701111165 SYRINGE, GLASS in 1 BOX (0270-1111-16) > 10 mL in 1 SYRINGE, GLASS1992-11-162023-05-31NoNoCurrent
0270-1111-45002701111455 SYRINGE, GLASS in 1 BOX (0270-1111-45) > 17 mL in 1 SYRINGE, GLASS1992-11-160000-00-00NoNoCurrent
0270-1111-70002701111705 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE2003-10-090000-00-00NoNoCurrent
0270-1111-85002701111855 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2022-02-010000-00-00NoNoCurrent