Indium In 111 Oxyquinoline

Product NDC
72536-0920
11-digit product format
725360920
Labeler code
72536
Product ID
72536-0920_0864f662-e3ce-4426-8c3c-e318f755a89d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indium In-111 Oxyquinoline
Dosage form
LIQUID
Route
INTRAVENOUS
Labeler
BWXT Medical Ltd.
Application
ANDA202586
Marketing category
ANDA
Marketing start
2019-09-27
Substance
INDIUM IN-111 OXYQUINOLINE
Active strength
1 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
Indium In 111 Oxyquinoline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDIUM IN-111 OXYQUINOLINE1 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLGX9OL562T

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43055ffe-41d2-43bd-8a82-6a956e857831Product name220250304
bbd6bead-5f01-4935-a7c1-b17c43e7374cProduct name120181004
d68e438a-7784-467d-ad60-7eef2f560f15Product name120151118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72536-0920-1Indium In 111 Oxyquinoline1 mL in 1 VIAL, SINGLE-DOSELIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72536-0920INDIUM IN 111 OXYQUINOLINE (INDIUM IN-111 OXYQUINOLINE) LIQUID [BWXT MEDICAL LTD.]4Current NDC, Legacy NDC, 1 package rows20241106_7dbfc0f9-0e2e-4aed-85bd-32cf7c74d402.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72536-0920-1725360920011 mL in 1 VIAL, SINGLE-DOSE (72536-0920-1) 1 ml2019-09-270000-00-00NoNoCurrent