FDA.reportPublic FDA data

Pentasa

Product NDC
54092-189
11-digit product format
540920189
Labeler code
54092
Product ID
54092-189_42661699-8fcc-40da-a05d-91906f9973e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
CAPSULE
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA020049
Marketing category
NDA
Marketing start
1993-05-10
Substance
MESALAMINE
Active strength
250 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pentasa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESALAMINE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui206791, 314092, 476362, 580286

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3Product name320260128
37997c2c-8686-b078-51f1-fb15da0c0a1cProduct name620260127
97851e97-0a12-4d74-aaa4-9583fe070304Product name220250318
194d5e54-52c4-1a5e-51c5-1224f8e44e49Product name520250317
4b8d62b1-86bf-0c4e-9f22-ebffb45e4564Product name520240514
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3Product name120230124
a4dbd90c-f616-c999-40d7-60da88952163Product name220190802
77831c26-5062-ed63-fc15-a07600377b5bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54092-189-81Pentasa240 in 1 BOTTLECAPSULE24042

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-189-81EA - Each54092-189e34db734-d988-4254-9773-bff80d3fa59a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MESALAMINEACTIVE INGREDIENT4Q81I59GXCPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
MESALAMINEACTIVE MOIETY4Q81I59GXCPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
GELATININACTIVE INGREDIENT2G86QN327LPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
TALCINACTIVE INGREDIENT7SEV7J4R1UPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]21
MESALAMINEACTIVE INGREDIENT4Q81I59GXCPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
MESALAMINEACTIVE MOIETY4Q81I59GXCPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-189PENTASA (MESALAMINE) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]42Current NDC, Legacy NDC, 1 package rows20250117_e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314092mesalamine 250 MG Extended Release Oral CapsulePSNe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
476362mesalamine 500 MG Extended Release Oral CapsulePSNe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
206791Pentasa 250 MG Extended Release Oral CapsulePSNe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
580286Pentasa 500 MG Extended Release Oral CapsulePSNe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
206791mesalamine 250 MG Extended Release Oral Capsule [Pentasa]SBDe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
580286mesalamine 500 MG Extended Release Oral Capsule [Pentasa]SBDe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
314092mesalamine 250 MG Extended Release Oral CapsuleSCDe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
476362mesalamine 500 MG Extended Release Oral CapsuleSCDe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
314092mesalazine 250 MG Extended Release Oral CapsuleSYe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
206791Pentasa 250 MG Extended Release Oral CapsuleSYe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
580286Pentasa 500 MG Extended Release Oral CapsuleSYe39d9a3d-5d3a-4bb6-aab1-fdbb2a59860642
314092mesalamine 250 MG Extended Release Oral CapsulePSNec53b1d4-b98d-4b4d-acc3-199f980319663
206791Pentasa 250 MG Extended Release Oral CapsulePSNec53b1d4-b98d-4b4d-acc3-199f980319663
206791mesalamine 250 MG Extended Release Oral Capsule [Pentasa]SBDec53b1d4-b98d-4b4d-acc3-199f980319663
314092mesalamine 250 MG Extended Release Oral CapsuleSCDec53b1d4-b98d-4b4d-acc3-199f980319663
314092mesalazine 250 MG Extended Release Oral CapsuleSYec53b1d4-b98d-4b4d-acc3-199f980319663
206791Pentasa 250 MG Extended Release Oral CapsuleSYec53b1d4-b98d-4b4d-acc3-199f980319663
314092mesalamine 250 MG Extended Release Oral CapsulePSN3a4dbb01-3c0f-4217-8e33-e372638788281
206791Pentasa 250 MG Extended Release Oral CapsulePSN3a4dbb01-3c0f-4217-8e33-e372638788281
206791mesalamine 250 MG Extended Release Oral Capsule [Pentasa]SBD3a4dbb01-3c0f-4217-8e33-e372638788281
314092mesalamine 250 MG Extended Release Oral CapsuleSCD3a4dbb01-3c0f-4217-8e33-e372638788281
314092mesalazine 250 MG Extended Release Oral CapsuleSY3a4dbb01-3c0f-4217-8e33-e372638788281
206791Pentasa 250 MG Extended Release Oral CapsuleSY3a4dbb01-3c0f-4217-8e33-e372638788281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54092-189-8154092018981240 CAPSULE in 1 BOTTLE (54092-189-81) 240 capsule1993-05-100000-00-00NoNoCurrent