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
f12ffa32-d14b-e9d9-e957-2ef08b64e8b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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
NDC Product Code60505-2575
Application NumberANDA077883
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 6, 2023
Generic NameBalsalazide Disodium
INGREDIENTS (9)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BALSALAZIDE DISODIUMActive
Quantity: 750 mg in 1 1
Code: 1XL6BJI034
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT