BLUDIGO
These highlights do not include all the information needed to use BLUDIGO safely and effectively. See full prescribing information for BLUDIGO. BLUDIGO™ (indigotindisulfonate sodium injection), forintravenous useInitial U.S. Approval: 2022
Approved
Approval ID
73f246c4-b127-452e-856f-134b56cb8870
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2023
Manufacturers
FDA
Provepharm Inc.
DUNS: 086861066
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
indigotindisulfonate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81284-315
Application NumberNDA216264
Product Classification
M
Marketing Category
C73594
G
Generic Name
indigotindisulfonate sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 2, 2022
FDA Product Classification
INGREDIENTS (3)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
INDIGOTINDISULFONATE SODIUMActive
Quantity: 8 mg in 1 mL
Code: D3741U8K7L
Classification: ACTIB