FDA.reportPublic FDA data

mesalamine

Product NDC
70771-1110
11-digit product format
707711110
Labeler code
70771
Product ID
70771-1110_b22ba9c9-d644-4ea2-a21d-0f8dee960c43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203286
Marketing category
ANDA
Marketing start
2018-08-02
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
70771-1110-2mesalamine10 in 1 BLISTER PACKTABLET, DELAYED RELEASE107
70771-1110-4mesalamine10 in 1 CARTONTABLET, DELAYED RELEASE107
70771-1110-8mesalamine180 in 1 BOTTLETABLET, DELAYED RELEASE1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1110MESALAMINE TABLET, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 3 package rows20241204_52d96501-47f3-45d8-a181-98763b9f8965.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833234mesalamine 800 MG Delayed Release Oral TabletPSN52d96501-47f3-45d8-a181-98763b9f89657
833234mesalamine 800 MG Delayed Release Oral TabletSCD52d96501-47f3-45d8-a181-98763b9f89657
833234mesalazine 800 MG Delayed Release Oral TabletSY52d96501-47f3-45d8-a181-98763b9f89657

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1110-27077111100210 in 1 BLISTER PACKHistorical
70771-1110-47077111100410 BLISTER PACK in 1 CARTON (70771-1110-4) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70771-1110-2) 10 blister pack2018-08-020000-00-00NoNoCurrent
70771-1110-870771111008180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1110-8) 2018-08-020000-00-00NoNoCurrent