Ammonia N 13
These highlights do not include all the information needed to use AMMONIA N13 INJECTION safely and effectively. See full prescribing information for AMMONIA N13 INJECTION. AMMONIA N13 INJECTION for intravenous use Initial U.S. Approval: 2007
Approved
Approval ID
57947a8c-939e-4468-805c-2f2001041fe4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 25, 2021
Manufacturers
FDA
Massachusetts General Hospital
DUNS: 156293698
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 Code76318-643
Application NumberANDA207025
Product Classification
M
Marketing Category
C73584
G
Generic Name
ammonia n-13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 24, 2019
FDA Product Classification
INGREDIENTS (3)
AMMONIA N-13Active
Quantity: 37.5 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT