Azulfidine
Azulfidine sulfasalazine tablets, USP
Approved
Approval ID
ddbe69f3-bd55-45f3-a64f-f60226c744c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2022
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
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 Code0013-0101
Application NumberNDA007073
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sulfasalazine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2022
FDA Product Classification
INGREDIENTS (5)
SULFASALAZINEActive
Quantity: 500 mg in 1 1
Code: 3XC8GUZ6CB
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT