Ammonia N 13

Product NDC
49609-201
11-digit product format
496090201
Labeler code
49609
Product ID
49609-201_1e90547c-5db8-479a-a76a-ef7888025f1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonia N-13
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
SOFIE Co.
Application
ANDA204667
Marketing category
ANDA
Marketing start
2013-01-31
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49609-201-014960902010130 mL in 1 VIAL, MULTI-DOSE (49609-201-01) 30 ml2013-01-310000-00-00NoNoCurrent