FDA.reportPublic FDA data

Mesalamine

Product NDC
31722-043
11-digit product format
317220043
Labeler code
31722
Product ID
31722-043_116b9d88-f7d4-f30e-e063-6394a90a3912
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216334
Marketing category
ANDA
Marketing start
2024-02-05
Substance
MESALAMINE
Active strength
1.2 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
MESALAMINE1.2 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui686429

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
31722-043-05Mesalamine500 in 1 BOTTLETABLET, DELAYED RELEASE5001
31722-043-12Mesalamine120 in 1 BOTTLETABLET, DELAYED RELEASE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-043-12EA - Each31722-0435e1c6bab-033a-431c-80b9-ccd3fd56255f12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-043MESALAMINE TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240216_04ce2182-2e8c-4598-a269-550cfaddde6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686429mesalamine 1.2 GM Delayed Release Oral Tablet, Once-DailyPSN04ce2182-2e8c-4598-a269-550cfaddde6c1
686429mesalamine 1200 MG Delayed Release Oral TabletSCD04ce2182-2e8c-4598-a269-550cfaddde6c1
686429mesalazine 1.2 GM Delayed Release Oral TabletSY04ce2182-2e8c-4598-a269-550cfaddde6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-043-0531722004305500 TABLET, DELAYED RELEASE in 1 BOTTLE (31722-043-05) 2024-02-05NoNoCurrent
31722-043-1231722004312120 TABLET, DELAYED RELEASE in 1 BOTTLE (31722-043-12) 2024-02-05NoNoCurrent