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 USP for Intravenous Use Initial U.S. Approval: 2007
Approved
Approval ID
cc430bfd-6940-41ca-bda4-6d29eb4dc1f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2023
Manufacturers
FDA
Precision Nuclear LLC
DUNS: 879283633
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 Code52768-100
Application NumberANDA204547
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMMONIA N-13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
AMMONIA N-13Active
Quantity: 260 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB
Drug Labeling Information
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 5/31/2022
7 DRUG INTERACTIONS
The possibility of interactions of Ammonia N 13 Injection with other drugs taken by patients undergoing PET imaging has not been studied.