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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-191
Application NumberNDA020049
Product Classification
M
Marketing Category
C73594
G
Generic Name
mesalamine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-189
Application NumberNDA020049
Product Classification
M
Marketing Category
C73594
G
Generic Name
mesalamine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2023
FDA Product Classification
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