FDA.reportPublic FDA data

Mesalamine

Product NDC
72162-2302
11-digit product format
721622302
Labeler code
72162
Product ID
72162-2302_8968031d-ec7a-4e71-adae-93baa739fc85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
SUSPENSION
Route
RECTAL
Labeler
Bryant Ranch Prepack
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
72162-2302-2Mesalamine60 mL in 1 BOTTLE, DISPENSINGSUSPENSION60101
72162-2302-2Mesalamine7 in 1 CARTONSUSPENSION7101
72162-2302-4Mesalamine60 mL in 1 BOTTLE, DISPENSINGSUSPENSION60101
72162-2302-4Mesalamine28 in 1 CARTONSUSPENSION28101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2302-2ML - Milliliter72162-23028668e8af-a56b-40ad-a885-4f1f93954c7f12024-06-10
72162-2302-4ML - Milliliter72162-230276f2f318-3551-4999-ba13-b20371b07f3512024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2302MESALAMINE SUSPENSION [BRYANT RANCH PREPACK]101Current NDC, 4 package rows20240502_c9b1ef9d-1d06-48e7-87d2-7985b99124a6.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2302-2721622302027 BOTTLE, DISPENSING in 1 CARTON (72162-2302-2) / 60 mL in 1 BOTTLE, DISPENSING2024-04-30NoNoCurrent
72162-2302-47216223020428 BOTTLE, DISPENSING in 1 CARTON (72162-2302-4) / 60 mL in 1 BOTTLE, DISPENSING2024-04-30NoNoCurrent