Ammonia N 13

Product NDC
40089-113
11-digit product format
400890113
Labeler code
40089
Product ID
40089-113_4123350b-7aed-3663-e063-6394a90ac1eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NH3N13
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
The Johns Hopkins University
Application
ANDA204514
Marketing category
ANDA
Marketing start
2012-03-21
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
40089-113-20Ammonia N 1320 mL in 1 VIAL, GLASSINJECTION2014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIA N-13ACTIVE INGREDIENT9OQO0E343ZAMMONIA N 13 (NH3N13) INJECTION [THE JOHNS HOPKINS UNIVERSITY]5
AMMONIA N-13ACTIVE MOIETY9OQO0E343ZAMMONIA N 13 (NH3N13) INJECTION [THE JOHNS HOPKINS UNIVERSITY]5
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XAMMONIA N 13 (NH3N13) INJECTION [THE JOHNS HOPKINS UNIVERSITY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40089-113AMMONIA N 13 (NH3N13) INJECTION [THE JOHNS HOPKINS UNIVERSITY]13Current NDC, Legacy NDC, 1 package rows20241023_80121d8f-fb9d-4122-9e12-33b4ba4f2b9a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40089-113-204008901132020 mL in 1 VIAL, GLASS (40089-113-20) 20 ml2012-03-210000-00-00NoNoCurrent