FDA.reportPublic FDA data

mesalamine

Product NDC
68382-711
11-digit product format
683820711
Labeler code
68382
Product ID
68382-711_d9ce9589-6aee-4dc3-a71b-f1c32ab9f552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA091640
Marketing category
ANDA
Marketing start
2017-06-19
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
68382-711-19mesalamine120 in 1 BOTTLETABLET, DELAYED RELEASE12015
68382-711-64mesalamine34 in 1 BOTTLETABLET, DELAYED RELEASE3415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-711-19EA - Each68382-711d3698477-b821-4763-820d-ec5160ac994512017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-711MESALAMINE TABLET, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 2 package rows20231103_533bfaf5-0add-4b49-a4f2-ddea2b83f65d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686429mesalamine 1.2 GM Delayed Release Oral Tablet, Once-DailyPSN533bfaf5-0add-4b49-a4f2-ddea2b83f65d15
686429mesalamine 1200 MG Delayed Release Oral TabletSCD533bfaf5-0add-4b49-a4f2-ddea2b83f65d15
686429mesalazine 1.2 GM Delayed Release Oral TabletSY533bfaf5-0add-4b49-a4f2-ddea2b83f65d15
686429mesalamine 1.2 GM Delayed Release Oral Tablet, Once-DailyPSN14ac4435-903b-41f5-a3c4-8c73de3e4cef7
686429mesalamine 1.2 GM Delayed Release Oral Tablet, Once-DailyPSN77140634-9f32-40ca-8c83-9fcc3e373c167
686429mesalamine 1200 MG Delayed Release Oral TabletSCD14ac4435-903b-41f5-a3c4-8c73de3e4cef7
686429mesalamine 1200 MG Delayed Release Oral TabletSCD77140634-9f32-40ca-8c83-9fcc3e373c167
686429mesalazine 1.2 GM Delayed Release Oral TabletSY14ac4435-903b-41f5-a3c4-8c73de3e4cef7
686429mesalazine 1.2 GM Delayed Release Oral TabletSY77140634-9f32-40ca-8c83-9fcc3e373c167
686429mesalamine 1.2 GM Delayed Release Oral Tablet, Once-DailyPSN170657d1-1f32-f036-e063-6294a90a4ed41
686429mesalamine 1200 MG Delayed Release Oral TabletSCD170657d1-1f32-f036-e063-6294a90a4ed41
686429mesalazine 1.2 GM Delayed Release Oral TabletSY170657d1-1f32-f036-e063-6294a90a4ed41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-711-1968382071119120 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-19) 2017-06-190000-00-00NoNoCurrent
68382-711-646838207116434 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-64) 2017-06-190000-00-00NoNoCurrent