Axumin
These highlights do not include all the information needed to use AXUMIN safely and effectively. See full prescribing information for AXUMIN. AXUMIN (fluciclovine F 18) injection, for intravenous use Initial U.S. Approval: 2016
Approved
Approval ID
389a502e-a7d5-43dd-b6bf-f022ff23f3b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Blue Earth Diagnostics
DUNS: 219742530
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluciclovine F-18
PRODUCT DETAILS
NDC Product Code69932-001
Application NumberNDA208054
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateDecember 8, 2023
Generic NameFluciclovine F-18
INGREDIENTS (5)
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FLUCICLOVINE F-18Active
Quantity: 221 mCi in 1 mL
Code: 38R1Q0L1ZE
Classification: ACTIB