Ammonia N 13

Product NDC
40028-513
11-digit product format
400280513
Labeler code
40028
Product ID
40028-513_4a821f06-a881-41f6-be44-60de3b6d83f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonia N-13
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
PETNET Solutions, Inc.
Application
ANDA204510
Marketing category
ANDA
Marketing start
2007-08-23
Marketing end
0000-00-00
Substance
AMMONIA N-13
Active strength
38 mCi/mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40028-513-302021-04-20C16284748780-1ba0f9c33-4716-a910-e053-dadaa90a0b8523595590-cd10-4850-9d6f-d13b76726237
40028-513-302021-01-29C16284748780-1ba0f9c33-4716-a910-e053-dadaa90a0b8523595590-cd10-4850-9d6f-d13b76726237

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
40028-513-30EA - Each40028-513fb0544e0-6828-4c33-b3f0-7812434953cd12024-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40028-513-304002805133030 mL in 1 VIAL, GLASS (40028-513-30) 30 ml2007-08-230000-00-00NoNoCurrent