Ammonia N 13
These highlights do not include all the information needed to use Ammonia N 13 Injection, USP safely and effectively. See full prescribing information for Ammonia N 13 Injection, USP. Ammonia N 13 Injection, USP for intravenous useInitial U.S. Approval: 2007
Approved
Approval ID
a4a2bb1a-1ecc-48e4-a87b-60fc583f61ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
Biomedical Research Foundation of Northwest Louisiana
DUNS: 184750008
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 Code24562-004
Application NumberANDA204352
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ammonia N-13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 12, 2015
FDA Product Classification
INGREDIENTS (2)
Sodium ChlorideInactive
Quantity: 0.9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Ammonia N-13Active
Quantity: 37.5 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB