Balsalazide Disodium
Balsalazide Disodium Capsules, USP 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. BALSALAZIDE DISODIUM capsules, for oral administration Initial U.S. Approval: 2000
Approved
Approval ID
509b83b6-cde6-393b-8560-557793b6a529
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvPAK
DUNS: 832926666
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 Code50268-102
Application NumberANDA077883
Product Classification
M
Marketing Category
C73584
G
Generic Name
Balsalazide Disodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
BALSALAZIDE DISODIUMActive
Quantity: 750 mg in 1 1
Code: 1XL6BJI034
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT