Pentasa
PENTASA (mesalamine) Extended-Release Capsules 250 mg and 500 mg
Approved
Approval ID
e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mesalamine
PRODUCT DETAILS
NDC Product Code54092-191
Application NumberNDA020049
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 24, 2023
Generic Namemesalamine
INGREDIENTS (8)
MESALAMINEActive
Quantity: 500 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
mesalamine
PRODUCT DETAILS
NDC Product Code54092-189
Application NumberNDA020049
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 24, 2023
Generic Namemesalamine
INGREDIENTS (10)
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MESALAMINEActive
Quantity: 250 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT