Irbesartan

Product NDC
63187-757
11-digit product format
631870757
Labeler code
63187
Product ID
63187-757_2203d183-4cf9-42a4-94b3-44651a4cbeeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRBESARTAN
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203071
Marketing category
ANDA
Marketing start
2012-09-27
Marketing end
0000-00-00
Substance
IRBESARTAN
Active strength
150 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-757-30EA - Each63187-757046767ef-a4fa-44e8-8577-b7ec6973104512016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-757IRBESARTAN TABLET [PROFICIENT RX LP]3Legacy NDC20191121_5c83ff4e-271c-4b66-903d-21c8455868c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-757-306318707573030 TABLET in 1 BOTTLE (63187-757-30) 30 tablet2016-10-030000-00-00NoNoCurrent
63187-757-606318707576060 TABLET in 1 BOTTLE (63187-757-60) 60 tablet2016-10-030000-00-00NoNoCurrent
63187-757-906318707579090 TABLET in 1 BOTTLE (63187-757-90) 90 tablet2016-10-030000-00-00NoNoCurrent