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
NDC Product Code81284-315
Application NumberNDA216264
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateSeptember 2, 2022
Generic Nameindigotindisulfonate sodium
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