Mesalamine Rectal

Product NDC
69918-560
11-digit product format
699180560
Labeler code
69918
Product ID
69918-560_795356f9-9817-4b51-8de6-4504a2a48abd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Amring Pharmaceuticals Inc.
Application
ANDA208362
Marketing category
ANDA
Marketing start
2019-06-24
Substance
MESALAMINE
Active strength
1000 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 Rectal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESALAMINE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui248420

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
69918-560-30Mesalamine Rectal30 in 1 BOXSUPPOSITORY307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69918-560-30EA - Each69918-56065f2e31b-36c8-4eae-b893-534bf0a3735912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69918-560MESALAMINE RECTAL (MESALAMINE) SUPPOSITORY [AMRING PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 1 package rows20231216_87de237c-febb-42ca-b2a4-b444396f8640.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248420mesalamine 1000 MG Rectal SuppositoryPSN87de237c-febb-42ca-b2a4-b444396f86407
248420mesalamine 1000 MG Rectal SuppositorySCD87de237c-febb-42ca-b2a4-b444396f86407
248420mesalazine 1000 MG Rectal SuppositorySY87de237c-febb-42ca-b2a4-b444396f86407

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69918-560-306991805603030 SUPPOSITORY in 1 BOX (69918-560-30) 30 suppository2019-06-240000-00-00NoNoCurrent