Sulfasalazine
Sulfasalazine Tablets, USP
Approved
Approval ID
76b532a3-e7ca-4929-8c51-c0f66e0806a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sulfasalazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6936
Application NumberNDA007073
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sulfasalazine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (8)
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SULFASALAZINEActive
Quantity: 500 mg in 1 1
Code: 3XC8GUZ6CB
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
ZEA MAYS (CORN) STARCHInactive
Code: O8232NY3SJ
Classification: IACT