FDA.reportPublic FDA data

Lialda

Product NDC
54092-476
11-digit product format
540920476
Labeler code
54092
Product ID
54092-476_405a190f-df13-4578-a988-5b291b284f21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA022000
Marketing category
NDA
Marketing start
2007-01-16
Substance
MESALAMINE
Active strength
1.2 g/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lialda
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESALAMINE1.2 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui686429, 686433

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
54092-476-01Lialda120 in 1 BOTTLETABLET, DELAYED RELEASE12049
54092-476-02Lialda12 in 1 CARTONTABLET, DELAYED RELEASE1249
54092-476-08Lialda3 in 1 CARTONTABLET, DELAYED RELEASE349
54092-476-08Lialda8 in 1 CARTONTABLET, DELAYED RELEASE849
54092-476-12Lialda120 in 1 BOTTLETABLET, DELAYED RELEASE12049

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-476-01EA - Each54092-476123aaa47-c820-4ade-916f-2609eb968b4b12019-07-02
54092-476-02EA - Each54092-4767e8ae41d-e638-4076-acc1-0152c76d017812014-11-05
54092-476-12EA - Each54092-476671127db-f58f-41b9-97ce-cd7e0db7bca012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MESALAMINEACTIVE INGREDIENT4Q81I59GXCLIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
MESALAMINEACTIVE MOIETY4Q81I59GXCLIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZLIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WELIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
TALCINACTIVE INGREDIENT7SEV7J4R1ULIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-476LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]46Current NDC, Legacy NDC, 5 package rows20231104_3098a080-be86-4265-9818-7fc4beab77b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686433Lialda 1. 2 GM Delayed Release Oral Tablet, Once-DailyPSN3098a080-be86-4265-9818-7fc4beab77b749
686429mesalamine 1.2 GM Delayed Release Oral Tablet, Once-DailyPSN3098a080-be86-4265-9818-7fc4beab77b749
686433mesalamine 1200 MG Delayed Release Oral Tablet [Lialda]SBD3098a080-be86-4265-9818-7fc4beab77b749
686429mesalamine 1200 MG Delayed Release Oral TabletSCD3098a080-be86-4265-9818-7fc4beab77b749
686433Lialda 1.2 GM Delayed Release Oral TabletSY3098a080-be86-4265-9818-7fc4beab77b749
686433Lialda 1200 MG Delayed Release Oral TabletSY3098a080-be86-4265-9818-7fc4beab77b749
686429mesalazine 1.2 GM Delayed Release Oral TabletSY3098a080-be86-4265-9818-7fc4beab77b749

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54092-476-0154092047601120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01) 2007-01-160000-00-00NoNoCurrent
54092-476-025409204760212 BOTTLE in 1 CARTON (54092-476-02) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01) 12 bottle2007-01-160000-00-00NoNoCurrent
54092-476-08540920476083 CARTON in 1 CARTON (54092-476-08) / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2007-01-160000-00-00NoNoCurrent
54092-476-1254092047612120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12) 2007-01-160000-00-00NoNoCurrent