FDA.reportPublic FDA data

CERIANNA

Product NDC
72874-001
11-digit product format
728740001
Labeler code
72874
Product ID
72874-001_fd28ffaf-5b17-43e7-bc91-fd623819340e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOROESTRADIOL F 18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
GE Healthcare Inc.
Application
NDA212155
Marketing category
NDA
Marketing start
2020-05-20
Substance
FLUOROESTRADIOL F-18
Active strength
100 mCi/mL
Pharmacologic classes
Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOROESTRADIOL F-18100 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT32277KB09

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5297523-74c1-4564-b7d9-d982881c176fProduct name120201021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72874-001-01CERIANNA50 mL in 1 VIAL, MULTI-DOSEINJECTION5027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72874-001CERIANNA (FLUOROESTRADIOL F 18) INJECTION [GE HEALTHCARE INC.]21Current NDC, Legacy NDC, 1 package rows20250126_b2c2a2df-cf3e-4a29-a033-231ed5a94b58.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72874-001-017287400010150 mL in 1 VIAL, MULTI-DOSE (72874-001-01) 50 ml2020-05-200000-00-00NoNoCurrent