Ammonia
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
26572b37-0999-4c83-8206-1c088026d407
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Kreitchman PET Center
DUNS: 010861487
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 Code62072-456
Application NumberANDA203938
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMMONIA N-13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 17, 2020
FDA Product Classification
INGREDIENTS (1)
AMMONIA N-13Active
Quantity: 37.5 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB