Ammonia N 13
These highlights do not include all the information needed to use AMMONIA N 13 INJECTION for intravenous use 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
bbc03271-8d23-4e89-aa32-cff581cdc275
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
University of Alabama at Birmingham
DUNS: 063690705
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NH3N13
PRODUCT DETAILS
NDC Product Code69714-001
Application NumberANDA211698
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJune 12, 2019
Generic NameNH3N13
INGREDIENTS (2)
AMMONIA N-13Active
Quantity: 37.5 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT