Ammonia
These highlights do not include all the information needed to use Ammonia N 13 Injection 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
85882893-0661-46c2-a5f2-a73f6ea4fb5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2020
Manufacturers
FDA
SOFIE Co. dba SOFIE
DUNS: 957704737
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 Code49609-003
Application NumberANDA203543
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMMONIA N-13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 8, 2020
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
AMMONIA N-13Active
Quantity: 260 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB