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 use Initial U.S. Approval: 2007

Approved

Approval ID

af70d0da-1c2d-44e4-b4cd-7cce6636c7b9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 4, 2023

Manufacturers

FDA

Mayo Clinic

DUNS: 167141923

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

NDC Product Code52670-552

Application NumberANDA203321

Marketing CategoryC73584

Route of AdministrationINTRAVENOUS

Effective DateDecember 4, 2023

Generic Nameammonia n-13

INGREDIENTS (2)

AMMONIA N-13Active

Quantity: 37.5 mCi in 1 mL

Code: 9OQO0E343Z

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT