FDA.reportPublic FDA data

Mesalamine

Product NDC
21922-045
11-digit product format
219220045
Labeler code
21922
Product ID
21922-045_6ffc01fa-3cf5-4e6c-9760-7ff9873c82df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
SUSPENSION
Route
RECTAL
Labeler
Encube Ethicals, Inc.
Application
ANDA216941
Marketing category
ANDA
Marketing start
2023-06-01
Substance
MESALAMINE
Active strength
4 g/60mL
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
MESALAMINE4 g/60mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui238151

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3Product name320260128
37997c2c-8686-b078-51f1-fb15da0c0a1cProduct name620260127
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
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
21922-045-01Mesalamine60 mL in 1 BOTTLE, DISPENSINGSUSPENSION606
21922-045-47Mesalamine7 in 1 CARTONSUSPENSION76
21922-045-49Mesalamine28 in 1 CARTONSUSPENSION286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-045-47ML - Milliliter21922-045a3151a33-d466-4e36-a281-5635e7be51f612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-045MESALAMINE SUSPENSION [ENCUBE ETHICALS PRIVATE LIMITED]4Current NDC, 3 package rows20240808_d6b68275-b2a4-4965-9862-cf14acf8c599.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238151mesalamine 4 GM in 60 mL EnemaPSNc9b1ef9d-1d06-48e7-87d2-7985b99124a6101
238151mesalamine 66.7 MG/ML EnemaSCDc9b1ef9d-1d06-48e7-87d2-7985b99124a6101
238151mesalamine 4 GM per 60 ML EnemaSYc9b1ef9d-1d06-48e7-87d2-7985b99124a6101
238151mesalazine 66.7 MG/ML EnemaSYc9b1ef9d-1d06-48e7-87d2-7985b99124a6101
238151mesalamine 4 GM in 60 mL EnemaPSNd6b68275-b2a4-4965-9862-cf14acf8c5996
238151mesalamine 66.7 MG/ML EnemaSCDd6b68275-b2a4-4965-9862-cf14acf8c5996
238151mesalamine 4 GM per 60 ML EnemaSYd6b68275-b2a4-4965-9862-cf14acf8c5996
238151mesalazine 66.7 MG/ML EnemaSYd6b68275-b2a4-4965-9862-cf14acf8c5996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-045-012192200450160 mL in 1 BOTTLE, DISPENSING60 mlHistorical
21922-045-47219220045477 BOTTLE, DISPENSING in 1 CARTON (21922-045-47) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) 2023-06-01NoNoCurrent
21922-045-492192200454928 BOTTLE, DISPENSING in 1 CARTON (21922-045-49) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) 2023-06-01NoNoCurrent