Mesalamine

Product NDC
60687-408
11-digit product format
606870408
Labeler code
60687
Product ID
60687-408_276fafe8-8a19-bee4-e063-6394a90a80a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203286
Marketing category
ANDA
Marketing start
2019-04-17
Substance
MESALAMINE
Active strength
800 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
Mesalamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESALAMINE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui833234

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
60687-408-25Mesalamine30 in 1 BOX, UNIT-DOSETABLET, DELAYED RELEASE306
60687-408-95Mesalamine1 in 1 BLISTER PACKTABLET, DELAYED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-408-25EA - Each60687-4080b515e5e-9654-47b0-b5ec-d8de7593030b12019-02-13
60687-408-95EA - Each60687-408da3c9917-5578-498d-9855-ff214e7fe72b12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-408MESALAMINE TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20241123_a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833234mesalamine 800 MG Delayed Release Oral TabletPSNa74ab9f4-ffcd-4bbf-88a5-342e6a38aabb6
833234mesalamine 800 MG Delayed Release Oral TabletSCDa74ab9f4-ffcd-4bbf-88a5-342e6a38aabb6
833234mesalazine 800 MG Delayed Release Oral TabletSYa74ab9f4-ffcd-4bbf-88a5-342e6a38aabb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-408-256068704082530 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-408-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-408-95) 30 blister pack2019-04-170000-00-00NoNoCurrent
60687-408-95606870408951 in 1 BLISTER PACKHistorical