AMMONIA N 13

Product NDC
81365-002
11-digit product format
813650002
Labeler code
81365
Product ID
81365-002_9082731f-17a8-4c71-973a-a0de0349cec9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMMONIA N-13
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Wisconsin Medical Radiopharmacy, LLC
Application
ANDA204356
Marketing category
ANDA
Marketing start
2014-12-23
Marketing end
0000-00-00
Substance
AMMONIA N-13
Active strength
260 mCi/mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81365-002-308136500023030 mL in 1 VIAL, MULTI-DOSE (81365-002-30) 30 ml2014-12-230000-00-00NoNoCurrent