Ammonia N 13
These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 2007
Approved
Approval ID
23595590-cd10-4850-9d6f-d13b76726237
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
PETNET Solutions, Inc.
DUNS: 015223951
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ammonia N-13
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40028-513
Application NumberANDA204510
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ammonia N-13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
AMMONIA N-13Active
Quantity: 37.5 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB