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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69714-001
Application NumberANDA211698
Product Classification
M
Marketing Category
C73584
G
Generic Name
NH3N13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 12, 2019
FDA Product Classification
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