Balsalazide Disodium
These highlights do not include all the information needed to use BALSALAZIDE DISODIUM CAPSULES safely and effectively. See full prescribing information for BALSALAZIDE DISODIUM CAPSULES. Initial U.S. Approval: 2000
Approved
Approval ID
cd73c9f1-d83b-4206-b2c6-1bd111e11263
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Balsalazide Disodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72162-2095
Application NumberANDA077883
Product Classification
M
Marketing Category
C73584
G
Generic Name
Balsalazide Disodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (8)
BALSALAZIDE DISODIUMActive
Quantity: 750 mg in 1 1
Code: 1XL6BJI034
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT