Ammonia N 13

Product NDC
13108-311
11-digit product format
131080311
Labeler code
13108
Product ID
13108-311_b7c487bc-f722-96ce-e053-2995a90a3436
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonia N 13
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
NukeMed, Inc. dba SpectronRx
Application
ANDA204455
Marketing category
ANDA
Marketing start
2015-04-24
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13108-311-25131080311251 mL in 1 VIAL, GLASS (13108-311-25) 1 ml2015-04-240000-00-00NoNoCurrent