FDA.reportPublic FDA data

Mesalamine

Product NDC
45802-923
11-digit product format
458020923
Labeler code
45802
Product ID
45802-923_9e3de2df-02db-474c-9e16-47aeea34b2c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
KIT
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA076751
Marketing category
ANDA
Marketing start
2009-09-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui238151

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3Product name320260128
37997c2c-8686-b078-51f1-fb15da0c0a1cProduct name620260127
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
97851e97-0a12-4d74-aaa4-9583fe070304Product name220250318
194d5e54-52c4-1a5e-51c5-1224f8e44e49Product name520250317
4b8d62b1-86bf-0c4e-9f22-ebffb45e4564Product name520240514
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3Product name120230124
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
a4dbd90c-f616-c999-40d7-60da88952163Product name220190802
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
77831c26-5062-ed63-fc15-a07600377b5bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-098-46Mesalamine60 mL in 1 BOTTLEENEMA420 mL4 g in 60mL14
45802-923-41Mesalamine1 in 1 CARTONKIT114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-923-41EA - Each45802-923ff56bce9-918f-4737-9443-505a0c3cc29212012-07-24
45802-923-49EA - Each45802-923730d663e-9f62-4882-a01f-5031f344fdba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MESALAMINEACTIVE INGREDIENT4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]3
MESALAMINEACTIVE MOIETY4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]3
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31MESALAMINE KIT [PERRIGO NEW YORK INC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMESALAMINE KIT [PERRIGO NEW YORK INC]3
POTASSIUM ACETATEINACTIVE INGREDIENTM911911U02MESALAMINE KIT [PERRIGO NEW YORK INC]3
POTASSIUM METABISULFITEINACTIVE INGREDIENT65OE787Q7WMESALAMINE KIT [PERRIGO NEW YORK INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMESALAMINE KIT [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0RMESALAMINE KIT [PERRIGO NEW YORK INC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMESALAMINE KIT [PERRIGO NEW YORK INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-923MESALAMINE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]14Current NDC, Legacy NDC, 2 package rows20241017_d50f2c37-5675-49f3-bdd4-3b16d333ed40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238151mesalamine 4 GM in 60 mL EnemaPSN9756d07b-2939-460f-94d3-e338c28cb993106
238151mesalamine 66.7 MG/ML EnemaSCD9756d07b-2939-460f-94d3-e338c28cb993106
238151mesalamine 4 GM per 60 ML EnemaSY9756d07b-2939-460f-94d3-e338c28cb993106
238151mesalazine 66.7 MG/ML EnemaSY9756d07b-2939-460f-94d3-e338c28cb993106
238151mesalamine 4 GM in 60 mL EnemaPSNd50f2c37-5675-49f3-bdd4-3b16d333ed4014
238151mesalamine 66.7 MG/ML EnemaSCDd50f2c37-5675-49f3-bdd4-3b16d333ed4014
238151mesalamine 4 GM per 60 ML EnemaSYd50f2c37-5675-49f3-bdd4-3b16d333ed4014
238151mesalazine 66.7 MG/ML EnemaSYd50f2c37-5675-49f3-bdd4-3b16d333ed4014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-098-464580200984660 mL in 1 BOTTLE60 mlHistorical
45802-923-41458020923411 KIT in 1 CARTON (45802-923-41) * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET1 kit2009-09-010000-00-00NoNoCurrent