FDA.reportPublic FDA data

sfRowasa

Product NDC
0037-0022
11-digit product format
000370022
Labeler code
0037
Product ID
0037-0022_37493a98-a4eb-42d3-8eff-5bf90c4a7f26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
SUSPENSION
Route
RECTAL
Labeler
Viatris Specialty LLC
Application
NDA019618
Marketing category
NDA
Marketing start
2016-03-24
Marketing end
2026-07-31
Substance
MESALAMINE
Active strength
4 g/60mL
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
sfRowasa
Brand name suffix
Sulfite-Free Formulation

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESALAMINE4 g/60mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui206798, 238151

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
0037-0022-07sfRowasaSulfite-Free Formulation7 in 1 CARTONSUSPENSION712
0037-0022-28sfRowasaSulfite-Free Formulation28 in 1 CARTONSUSPENSION2812
0037-0022-60sfRowasaSulfite-Free Formulation60 mL in 1 BOTTLE, WITH APPLICATORSUSPENSION6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-0022-07ML - Milliliter0037-0022b655b60a-54da-4a52-9309-b8c37f9de1e512016-05-16
0037-0022-28ML - Milliliter0037-00227634d71d-2b91-4464-8ee2-7e62cde4363312016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0037-0022SFROWASA SULFITE-FREE FORMULATION (MESALAMINE) SUSPENSION [MEDA PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 3 package rows20241011_aa273fdc-f7c4-4901-8f71-59ae03b8cdb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238151mesalamine 4 GM in 60 mL EnemaPSNaa273fdc-f7c4-4901-8f71-59ae03b8cdb112
206798sfRowasa 4 GM in 60 mL EnemaPSNaa273fdc-f7c4-4901-8f71-59ae03b8cdb112
206798mesalamine 66.7 MG/ML Enema [Rowasa]SBDaa273fdc-f7c4-4901-8f71-59ae03b8cdb112
238151mesalamine 66.7 MG/ML EnemaSCDaa273fdc-f7c4-4901-8f71-59ae03b8cdb112
238151mesalamine 4 GM per 60 ML EnemaSYaa273fdc-f7c4-4901-8f71-59ae03b8cdb112
238151mesalazine 66.7 MG/ML EnemaSYaa273fdc-f7c4-4901-8f71-59ae03b8cdb112
206798Rowasa 4 GM per 60 ML EnemaSYaa273fdc-f7c4-4901-8f71-59ae03b8cdb112
206798Rowasa 66.7 MG/ML EnemaSYaa273fdc-f7c4-4901-8f71-59ae03b8cdb112
206798sfRowasa 4 GM per 60 ML EnemaSYaa273fdc-f7c4-4901-8f71-59ae03b8cdb112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-0022-07000370022077 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60) 2016-03-242026-07-31NoNoCurrent
0037-0022-280003700222828 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60) 2016-05-242026-07-31NoNoCurrent
0037-0022-600003700226060 mL in 1 BOTTLE, WITH APPLICATOR60 mlHistorical