Ammonia N 13
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2007
Approved
Approval ID
d24f8595-2231-4f15-ac2b-9148ec453324
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2019
Manufacturers
FDA
Decatur Memorial Hospital
DUNS: 046584991
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 Code73410-001
Application NumberANDA204465
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ammonia N 13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 6, 2019
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