FDA.reportPublic FDA data

Vizamyl

Product NDC
17156-067
11-digit product format
171560067
Labeler code
17156
Product ID
17156-067_4fda8ebc-b46e-4d12-9c45-8cbb3a2516bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flutemetamol F-18
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)
Application
NDA203137
Marketing category
NDA
Marketing start
2014-01-01
Substance
FLUTEMETAMOL F-18
Active strength
4.05 mCi/mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTEMETAMOL F-184.05 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL49M066S0O

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7d2a386d-5a97-4183-96c5-4c9fa792f396Product name120160112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17156-067-10Vizamyl1 in 1 CONTAINERSOLUTION131
17156-067-10Vizamyl10 mL in 1 VIAL, MULTI-DOSESOLUTION1031
17156-067-30Vizamyl1 in 1 CONTAINERSOLUTION131
17156-067-30Vizamyl30 mL in 1 VIAL, MULTI-DOSESOLUTION3031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17156-067-10EA - Each17156-067d43e4077-e912-4938-8d11-2d4b458f791912016-03-04
17156-067-30EA - Each17156-067347b2131-7925-4494-8481-45a32d7c94e812016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Flutemetamol F-18ACTIVE INGREDIENTL49M066S0OVIZAMYL (FLUTEMETAMOL F-18) SOLUTION [MEDI-PHYSICS INC.]4
Flutemetamol F-18ACTIVE MOIETYL49M066S0OVIZAMYL (FLUTEMETAMOL F-18) SOLUTION [MEDI-PHYSICS INC.]4
AlcoholINACTIVE INGREDIENT3K9958V90MVIZAMYL (FLUTEMETAMOL F-18) SOLUTION [MEDI-PHYSICS INC.]4
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HVIZAMYL (FLUTEMETAMOL F-18) SOLUTION [MEDI-PHYSICS INC.]4
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XVIZAMYL (FLUTEMETAMOL F-18) SOLUTION [MEDI-PHYSICS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17156-067VIZAMYL (FLUTEMETAMOL F-18) SOLUTION [MEDI-PHYSICS, INC. DBA GE HEALTHCARE]18Current NDC, Legacy NDC, 4 package rows20250514_b3558f16-8f9a-4e55-8d9c-836427ebaa57.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17156-067-10171560067101 in 1 CONTAINERHistorical
17156-067-30171560067301 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE2014-03-010000-00-00NoNoCurrent