Vueway

Product NDC
0270-7030
11-digit product format
002707030
Labeler code
0270
Product ID
0270-7030_edc110ca-cf49-3620-34bb-cc6bc8c7a100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gadopiclenol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BRACCO DIAGNOSTICS INC
Application
NDA216986
Marketing category
NDA
Marketing start
2022-09-21
Substance
GADOPICLENOL
Active strength
485.1 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vueway
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOPICLENOL485.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS276568KOY

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
7de6d8a6-e2ca-4b92-a0a2-a9fccba6d53aProduct name120230905

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0270-7030-42Vueway10 in 1 CASEINJECTION109
0270-7030-42Vueway10 mL in 1 VIAL, SINGLE-DOSEINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0270-7030-42ML - Milliliter0270-703024ba6e0f-62cf-4f0d-bf62-a2459ff3f8b412023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0270-7030VUEWAY (GADOPICLENOL) INJECTION [BRACCO DIAGNOSTICS INC]6Current NDC, Legacy NDC, 2 package rows20240814_192725e9-e83e-1a36-33f2-abee55792ab3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0270-7030-420027070304210 VIAL, SINGLE-DOSE in 1 CASE (0270-7030-42) / 10 mL in 1 VIAL, SINGLE-DOSE2022-09-210000-00-00NoNoCurrent