Choline C 11

Product NDC
52670-556
11-digit product format
526700556
Labeler code
52670
Product ID
52670-556_46dfe43b-1bd0-57a8-e063-6294a90a4c40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Choline C-11
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mayo Clinic
Application
NDA203155
Marketing category
NDA
Marketing start
2012-09-12
Substance
CHOLINE C-11
Active strength
33.1 mCi/mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Choline C 11
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLINE C-1133.1 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM4AS4XGD4Q

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1acfa67-deca-4d07-9fa2-83d3856a0e25Product name420180131

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52670-556-30Choline C 1130 mL in 1 VIALINJECTION3010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHOLINE C-11ACTIVE INGREDIENTM4AS4XGD4QCHOLINE C 11 (CHOLINE C-11) INJECTION [MAYO CLINIC]3
CHOLINE C-11ACTIVE MOIETYM4AS4XGD4QCHOLINE C 11 (CHOLINE C-11) INJECTION [MAYO CLINIC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHOLINE C 11 (CHOLINE C-11) INJECTION [MAYO CLINIC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52670-556CHOLINE C 11 (CHOLINE C-11) INJECTION [MAYO CLINIC]9Current NDC, Legacy NDC, 1 package rows20241219_8e046642-5038-4094-b1bb-a1915558fb1c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52670-556-305267005563030 mL in 1 VIAL (52670-556-30) 30 ml2012-09-120000-00-00NoNoCurrent