Mesalamine
MESALAMINE EXTENDED-RELEASE CAPSULES, USP 500 mg Rx only
Approved
Approval ID
c2f84490-70b8-4998-907d-a77e9f791de1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mesalamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-089
Application NumberANDA214585
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mesalamine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2023
FDA Product Classification
INGREDIENTS (18)
MESALAMINEActive
Quantity: 500 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT