MedPath

LYMPHAZURIN

These highlights do not include all the information needed to use LYMPHAZURIN safely and effectively. See full prescribing information for LYMPHAZURIN. LYMPHAZURIN injection, solution for subcutaneous use Initial U.S. Approval: 1981

Approved
Approval ID

cbee4532-238b-4f91-86ae-f8c0c1b6d7da

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 31, 2012

Manufacturers
FDA

UNITED STATES SURGICAL CORPORATION

DUNS: 044680650

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 Code63261-250
Application NumberNDA018310
Product Classification
M
Marketing Category
C73594
G
Generic Name
isosulfan blue
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 23, 2011
FDA Product Classification

INGREDIENTS (4)

ISOSULFAN BLUEActive
Quantity: 10 mg in 1 mL
Code: 39N9K8S2A4
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

LYMPHAZURIN - FDA Drug Approval Details