Ammonia N 13

Product NDC
72333-001
11-digit product format
723330001
Labeler code
72333
Product ID
72333-001_4123288c-7d00-0b7b-e063-6394a90afb65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonia N 13
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
University of Wisconsin System
Application
ANDA211740
Marketing category
ANDA
Marketing start
2020-09-09
Substance
AMMONIA N-13
Active strength
37.5 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
Ammonia N 13
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMMONIA N-1337.5 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9OQO0E343Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8eb56be-edf0-4b39-8ab1-e48c4aa676efProduct name520220126
76ba8fa2-294c-406c-aab2-68cb80b6d1aaProduct name920210511
612e700f-023c-452e-a2e6-3ea15fd646dbProduct name120190416

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72333-001-10Ammonia N 1310 mL in 1 VIAL, GLASSINJECTION1013
72333-001-10Ammonia N 131 in 1 CONTAINERINJECTION113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72333-001AMMONIA N 13 INJECTION [UNIVERSITY OF WISCONSIN SYSTEM]12Current NDC, Legacy NDC, 2 package rows20241023_730595b1-605c-40a2-8f89-2c3eae98f88a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72333-001-10723330001101 VIAL, GLASS in 1 CONTAINER (72333-001-10) / 10 mL in 1 VIAL, GLASS2020-09-090000-00-00NoNoCurrent