FDA.reportPublic FDA data

APRISO

Product NDC
65649-103
11-digit product format
656490103
Labeler code
65649
Product ID
65649-103_0e88852d-72fc-3002-e063-6394a90a0369
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Salix Pharmaceuticals, Inc.
Application
NDA022301
Marketing category
NDA
Marketing start
2008-10-31
Substance
MESALAMINE
Active strength
375 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
APRISO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESALAMINE375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui825130, 825134

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
65649-103-01APRISO1 in 1 CARTONCAPSULE, EXTENDED RELEASE134
65649-103-01APRISO4 in 1 BOTTLECAPSULE, EXTENDED RELEASE434
65649-103-02APRISO120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12034
65649-103-02APRISO1 in 1 CARTONCAPSULE, EXTENDED RELEASE134

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65649-103-02EA - Each65649-103015fe0a2-3ab7-45ff-a42d-660a95ced15d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MESALAMINEACTIVE INGREDIENT4Q81I59GXCAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
MESALAMINEACTIVE MOIETY4Q81I59GXCAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
POVIDONEINACTIVE INGREDIENTFZ989GH94EAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
TALCINACTIVE INGREDIENT7SEV7J4R1UAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]14
MESALAMINEACTIVE INGREDIENT4Q81I59GXCAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MESALAMINEACTIVE MOIETY4Q81I59GXCAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAPRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65649-103APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]34Current NDC, Legacy NDC, 4 package rows20240110_7951139c-b271-45a4-b523-34b23800917b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
825134Apriso 0.375 GM 24HR Extended Release Oral CapsulePSN7951139c-b271-45a4-b523-34b23800917b34
825130mesalamine 0.375 GM 24HR Extended Release Oral CapsulePSN7951139c-b271-45a4-b523-34b23800917b34
82513424 HR mesalamine 375 MG Extended Release Oral Capsule [Apriso]SBD7951139c-b271-45a4-b523-34b23800917b34
82513024 HR mesalamine 375 MG Extended Release Oral CapsuleSCD7951139c-b271-45a4-b523-34b23800917b34
825134Apriso 375 MG 24 HR Extended Release Oral CapsuleSY7951139c-b271-45a4-b523-34b23800917b34
825130mesalamine 375 MG 24 HR Extended Release Oral CapsuleSY7951139c-b271-45a4-b523-34b23800917b34
825130mesalazine 375 MG 24 HR Extended Release Oral CapsuleSY7951139c-b271-45a4-b523-34b23800917b34
825134Apriso 0.375 GM 24HR Extended Release Oral CapsulePSNd5d05b1f-9f45-4f66-9f75-3c67934105de2
825130mesalamine 0.375 GM 24HR Extended Release Oral CapsulePSNd5d05b1f-9f45-4f66-9f75-3c67934105de2
82513424 HR mesalamine 375 MG Extended Release Oral Capsule [Apriso]SBDd5d05b1f-9f45-4f66-9f75-3c67934105de2
82513024 HR mesalamine 375 MG Extended Release Oral CapsuleSCDd5d05b1f-9f45-4f66-9f75-3c67934105de2
825134Apriso 375 MG 24 HR Extended Release Oral CapsuleSYd5d05b1f-9f45-4f66-9f75-3c67934105de2
825130mesalamine 375 MG 24 HR Extended Release Oral CapsuleSYd5d05b1f-9f45-4f66-9f75-3c67934105de2
825130mesalazine 375 MG 24 HR Extended Release Oral CapsuleSYd5d05b1f-9f45-4f66-9f75-3c67934105de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65649-103-01656490103011 BOTTLE in 1 CARTON (65649-103-01) / 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2008-10-310000-00-00YesNoCurrent
65649-103-02656490103021 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2008-10-310000-00-00NoNoCurrent