Isosulfan Blue
These highlights do not include all the information needed to use ISOSULFAN BLUE INJECTION 1% safely and effectively. See full prescribing information for ISOSULFAN BLUE INJECTION 1%. ISOSULFAN BLUE injection 1% for subcutaneous use onlyInitial U.S. Approval: 1981
Approved
Approval ID
1878964e-5220-48c8-a872-dcadbc451aff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2020
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-220
Application NumberANDA090874
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosulfan Blue
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 19, 2017
FDA Product Classification
INGREDIENTS (4)
ISOSULFAN BLUEActive
Quantity: 10 mg in 1 mL
Code: 39N9K8S2A4
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 6.6 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Quantity: 2.7 mg in 1 mL
Code: 4J9FJ0HL51
Classification: IACT