Ammonia

Product NDC
62072-456
11-digit product format
620720456
Labeler code
62072
Product ID
62072-456_bf01478c-3377-4b2c-905c-30807e865825
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMMONIA N-13
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Kreitchman PET Center
Application
ANDA203938
Marketing category
ANDA
Marketing start
2013-12-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ammonia
Brand name suffix
N 13
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62072-456-56AmmoniaN 138 mL in 1 VIAL, GLASSINJECTION87

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIA N-13ACTIVE INGREDIENT9OQO0E343ZAMMONIA N 13 (AMMONIA N-13) INJECTION [KREITCHMAN PET CENTER]1
AMMONIA N-13ACTIVE MOIETY9OQO0E343ZAMMONIA N 13 (AMMONIA N-13) INJECTION [KREITCHMAN PET CENTER]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62072-456AMMONIA N 13 (AMMONIA N-13) INJECTION [KREITCHMAN PET CENTER]6Current NDC, Legacy NDC, 1 package rows20240113_26572b37-0999-4c83-8206-1c088026d407.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62072-456-56620720456568 mL in 1 VIAL, GLASS (62072-456-56) 8 ml2013-12-090000-00-00NoNoCurrent