Ammonia N 13

Product NDC
13267-456
11-digit product format
132670456
Labeler code
13267
Product ID
13267-456_0bd46b33-99e9-4989-8816-182d7d72babb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NH3N13
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
Application
NDA022119
Marketing category
NDA
Marketing start
2007-08-23
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
13267-456-56Ammonia N 138 mL in 1 VIAL, GLASSINJECTION820191030

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIA N-13ACTIVE INGREDIENT9OQO0E343ZAMMONIA N 13 (NH3N13) INJECTION [THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH]1000
AMMONIA N-13ACTIVE MOIETY9OQO0E343ZAMMONIA N 13 (NH3N13) INJECTION [THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13267-456AMMONIA N 13 (NH3N13) INJECTION [THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH]20191030Current NDC, Legacy NDC, 1 package rows20191106_c857724f-b172-4844-ad42-6fa4c42b0405.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13267-456-56132670456568 mL in 1 VIAL, GLASS (13267-456-56) 8 ml2007-08-230000-00-00NoNoCurrent