Sodium Iodide I 131 Diagnostic

Product NDC
65174-461
11-digit product format
651740461
Labeler code
65174
Product ID
65174-461_6dfea844-f0a4-4485-b898-399267cccc2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Iodide I 131
Dosage form
CAPSULE
Route
ORAL
Labeler
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application
NDA021305
Marketing category
NDA
Marketing start
2006-05-01
Substance
SODIUM IODIDE I-131
Active strength
100 mCi/1
Pharmacologic classes
Radioactive Therapeutic 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
Sodium Iodide I 131 Diagnostic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM IODIDE I-131100 mCi/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii29VCO8ACHH

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
20ce01ac-ad85-424c-96b9-52d2671eb5b5Product name120200617
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65174-461-05Sodium Iodide I 131 Diagnostic5 in 1 VIALCAPSULE56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65174-461-05EA - Each65174-461470e92af-3543-42ab-a6ec-455dd51aafba12024-11-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65174-461SODIUM IODIDE I 131 DIAGNOSTIC (SODIUM IODIDE I 131) CAPSULE [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]6Current NDC, Legacy NDC, 1 package rows20200826_46b8d7ba-432d-d610-84f2-550bf9d0bae3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65174-461-05651740461055 CAPSULE in 1 VIAL (65174-461-05) 5 capsule2006-05-010000-00-00NoNoCurrent