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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

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Ammonia - FDA Drug Approval Details