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Ammonia N 13

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

23595590-cd10-4850-9d6f-d13b76726237

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 6, 2023

Manufacturers
FDA

PETNET Solutions, Inc.

DUNS: 015223951

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 Code40028-513
Application NumberANDA204510
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ammonia N-13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2023
FDA Product Classification

INGREDIENTS (2)

SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
AMMONIA N-13Active
Quantity: 37.5 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB

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Ammonia N 13 - FDA Drug Approval Details