AMMONIA N-13

Product NDC
24450-113
11-digit product format
244500113
Labeler code
24450
Product ID
24450-113_19040c38-c4fb-4162-9f11-b296c1e43736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMMONIA N-13
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Brigham and Women's Hospital, Inc., The
Application
ANDA203783
Marketing category
ANDA
Marketing start
2014-11-01
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
24450-113-10AMMONIA N-1310 mL in 1 VIAL, GLASSINJECTION107

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIA N-13ACTIVE INGREDIENT9OQO0E343ZAMMONIA N-13 INJECTION [BRIGHAM AND WOMEN'S HOSPITAL, INC., THE]1
AMMONIA N-13ACTIVE MOIETY9OQO0E343ZAMMONIA N-13 INJECTION [BRIGHAM AND WOMEN'S HOSPITAL, INC., THE]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XAMMONIA N-13 INJECTION [BRIGHAM AND WOMEN'S HOSPITAL, INC., THE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24450-113AMMONIA N-13 INJECTION [BRIGHAM AND WOMEN'S HOSPITAL, INC., THE]7Current NDC, Legacy NDC, 1 package rows20211104_3c3c98bd-a052-4564-a15f-37dc6d032707.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24450-113-102445001131010 mL in 1 VIAL, GLASS (24450-113-10) 10 ml2014-11-010000-00-00NoNoCurrent