Isosulfan Blue

Basic Information

Product Name

Isosulfan Blue

FDA Product Code

70069-221

Regulatory Information

NDC Product Code

70069-221

Application Number

ANDA210558

Marketing Category

C73584

Effective Date

July 23, 2019

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ISOSULFAN BLUE

Quantity: 10 mg in 1 mL

Code: 39N9K8S2A4

Class Code: ACTIB

POTASSIUM PHOSPHATE, MONOBASIC

Quantity: 2.7 mg in 1 mL

Code: 4J9FJ0HL51

Class Code: IACT

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Quantity: 6.6 mg in 1 mL

Code: 22ADO53M6F

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

ISOSULFAN BLUE INNER SALT

Code: NS6Q291771

Basic Information

Regulatory Information

Company Information

Active Ingredients

POTASSIUM PHOSPHATE, MONOBASIC

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

WATER

Active Moieties

ISOSULFAN BLUE INNER SALT