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, for subcutaneous useInitial U.S. Approval: 1981
Approved
Approval ID
a4c7400a-ff36-4a76-aa84-7f91e303f937
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 23, 2019
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
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 Code70069-221
Application NumberANDA210558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosulfan Blue
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 23, 2019
FDA Product Classification
INGREDIENTS (4)
ISOSULFAN BLUEActive
Quantity: 10 mg in 1 mL
Code: 39N9K8S2A4
Classification: ACTIB
POTASSIUM PHOSPHATE, MONOBASICInactive
Quantity: 2.7 mg in 1 mL
Code: 4J9FJ0HL51
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 6.6 mg in 1 mL
Code: 22ADO53M6F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT