Ammonia N-13
HIGHLIGHTS OF PRESCRIBING INFORMATION 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: 2021
Approved
Approval ID
c79222b1-7dd8-f1fe-e053-2a95a90a3639
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
The Methodist Hospital Research Institute
DUNS: 185641052
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 Code69864-002
Application NumberANDA215083
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ammonia N-13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
AMMONIA N-13Active
Quantity: 260 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB