Ammonia N 13

Product NDC

44338-002

11-digit product format

443380002

Labeler code

44338

Product ID

44338-002_236f6349-d80b-41a1-89cc-7ef5f1a1a482

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ammonia N-13

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Wisconsin Medical Cyclotron, 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

2020-12-31

Current FDA listing

Historical FDA.report record