Ga-68-DOTATOC

Product NDC
24417-681
11-digit product format
244170681
Labeler code
24417
Product ID
24417-681_d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EDOTREOTIDE GALLIUM GA-68
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
UIHC � P E T Imaging Center
Application
NDA210828
Marketing category
NDA
Marketing start
2019-09-01
Substance
EDOTREOTIDE GALLIUM GA-68
Active strength
4 mCi/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ga-68-DOTATOC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EDOTREOTIDE GALLIUM GA-684 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY68179SY2L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24417-681-30Ga-68-DOTATOC14 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24417-681GA-68-DOTATOC (EDOTREOTIDE GALLIUM GA-68) INJECTION, SOLUTION [UIHC – P E T IMAGING CENTER]3Current NDC, Legacy NDC, 1 package rows20211212_c4d185c3-d520-462d-ba50-4f4ee485ace3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24417-681-302441706813014 mL in 1 VIAL, MULTI-DOSE (24417-681-30) 14 ml2019-09-010000-00-00NoNoCurrent