Ammonia
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
4c563174-c7cd-4224-b865-4da2f39c21c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2018
Manufacturers
FDA
Cardinal Health 414, LLC
DUNS: 069410546
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 Code65857-200
Application NumberANDA203700
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ammonia N-13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 11, 2018
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
AMMONIA N-13Active
Quantity: 37.5 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB