Balsalazide Disodium
These highlights do not include all the information needed to use Balsalazide Disodium Capsules, 750 mg safely and effectively. See full prescribing information for Balsalazide Disodium Capsules. Balsalazide Disodium Capsules for oral useInitial U.S. Approval: 2000
Approved
Approval ID
3934dfa6-f2f7-4bdc-94fa-6c17224da61d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6137
Application NumberANDA077806
Product Classification
M
Marketing Category
C73584
G
Generic Name
Balsalazide Disodium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2011
FDA Product Classification
INGREDIENTS (14)
BALSALAZIDE DISODIUMActive
Quantity: 750 mg in 1 1
Code: 1XL6BJI034
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT