mesalamine

Product NDC
16714-830
11-digit product format
167140830
Labeler code
16714
Product ID
16714-830_3a536e32-ddd8-4e97-aad4-cb4f16a254d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC.
Application
ANDA091640
Marketing category
ANDA
Marketing start
2018-06-25
Marketing end
0000-00-00
Substance
MESALAMINE
Active strength
1 g/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-830-01EA - Each16714-83005245ac9-da4f-4dff-9c11-10ab802271ef12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-830MESALAMINE TABLET, DELAYED RELEASE [NORTHSTAR RX LLC.]11Legacy NDC20231230_34494be6-3db5-4349-ab2d-57e8ccb383fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686429mesalamine 1.2 GM Delayed Release Oral Tablet, Once-DailyPSNdd685633-e1ce-48d1-a47a-5c08dc39ee311
686429mesalamine 1200 MG Delayed Release Oral TabletSCDdd685633-e1ce-48d1-a47a-5c08dc39ee311
686429mesalazine 1.2 GM Delayed Release Oral TabletSYdd685633-e1ce-48d1-a47a-5c08dc39ee311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-830-0116714083001120 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-830-01) 2018-06-250000-00-00NoNoCurrent