Mesalamine

Product NDC
60687-556
11-digit product format
606870556
Labeler code
60687
Product ID
60687-556_26e14623-21ee-3358-e063-6394a90a311f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA207873
Marketing category
ANDA
Marketing start
2021-04-20
Substance
MESALAMINE
Active strength
400 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
MESALAMINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui1368954

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
60687-556-32Mesalamine20 in 1 BOX, UNIT-DOSECAPSULE, DELAYED RELEASE205
60687-556-33Mesalamine1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-556MESALAMINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20241116_c1ed6fcc-7fd4-4b8a-9ddb-e772ea930e9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1368954mesalamine 400 MG Delayed Release Oral CapsulePSNc1ed6fcc-7fd4-4b8a-9ddb-e772ea930e9e5
1368954mesalamine 400 MG Delayed Release Oral CapsuleSCDc1ed6fcc-7fd4-4b8a-9ddb-e772ea930e9e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-556-326068705563220 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-556-32) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-556-33) 20 blister pack2021-04-200000-00-00NoNoCurrent
60687-556-33606870556331 in 1 BLISTER PACKHistorical