FDA.reportPublic FDA data

Mesalamine

Product NDC
50268-577
11-digit product format
502680577
Labeler code
50268
Product ID
50268-577_2b4a9376-8515-3d10-e063-6394a90a0aad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA214242
Marketing category
ANDA
Marketing start
2023-01-16
Substance
MESALAMINE
Active strength
.375 g/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
Mesalamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESALAMINE.375 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui825130

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
50268-577-11Mesalamine1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE12
50268-577-15Mesalamine50 in 1 BOXCAPSULE, EXTENDED RELEASE502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-577-11EA - Each50268-57750986255-0b01-4674-8191-571b6488ce8c12023-02-06
50268-577-15EA - Each50268-57704b381a7-5201-436b-9c0b-6bb45e40743b12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-577MESALAMINE CAPSULE, EXTENDED RELEASE [AVPAK]2Current NDC, 2 package rows20250112_f2657911-6f06-71fb-e053-2a95a90ae6f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
825130mesalamine 0.375 GM 24HR Extended Release Oral CapsulePSNf2657911-6f06-71fb-e053-2a95a90ae6f72
82513024 HR mesalamine 375 MG Extended Release Oral CapsuleSCDf2657911-6f06-71fb-e053-2a95a90ae6f72
825130mesalamine 375 MG 24 HR Extended Release Oral CapsuleSYf2657911-6f06-71fb-e053-2a95a90ae6f72
825130mesalazine 375 MG 24 HR Extended Release Oral CapsuleSYf2657911-6f06-71fb-e053-2a95a90ae6f72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-577-11502680577111 in 1 BLISTER PACKHistorical
50268-577-155026805771550 BLISTER PACK in 1 BOX (50268-577-15) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-577-11) 50 blister pack2023-01-16NoNoHistorical