Isosulfan Blue
These highlights do not include all the information needed to use ISOSULFAN BLUE INJECTION safely and effectively. See full prescribing information for ISOSULFAN BLUE INJECTION. ISOSULFAN BLUE injection, for subcutaneous use only Initial U.S. Approval: 1981
Approved
Approval ID
61b48ff8-7ace-4ab7-9f58-f250e2830d16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2019
Manufacturers
FDA
AuroMedics Pharma LLC
DUNS: 968961354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isosulfan Blue
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-240
Application NumberANDA206831
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosulfan Blue
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 5, 2019
FDA Product Classification
INGREDIENTS (4)
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
ISOSULFAN BLUEActive
Quantity: 50 mg in 5 mL
Code: 39N9K8S2A4
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT