Ammonia

Product NDC
16129-003
11-digit product format
161290003
Labeler code
16129
Product ID
16129-003_f0301006-6d22-de9c-e053-2995a90a75e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMMONIA N-13
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Shertech Laboratories, LLC
Application
ANDA204366
Marketing category
ANDA
Marketing start
2012-06-12
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16129-003-301612900033030 mL in 1 VIAL, GLASS (16129-003-30) 30 ml2012-06-120000-00-00NoNoCurrent