Irbesartan

Product NDC
69367-120
11-digit product format
693670120
Labeler code
69367
Product ID
69367-120_4f0ce3cf-9eb2-40fe-8f3d-cf9228935c45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA204774
Marketing category
ANDA
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
IRBESARTAN
Active strength
150 mg/150mg
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-120-01EA - Each69367-1200f44583b-dceb-4695-b4ff-0626cf4901eb12016-02-04
69367-120-03EA - Each69367-1207e98513d-1cdd-4fd8-8876-90e0a0a518f612016-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-120-016936701200130 mg in 1 BOTTLE (69367-120-01) 30 mg2016-02-010000-00-00NoNoCurrent
69367-120-036936701200390 mg in 1 BOTTLE (69367-120-03) 90 mg2016-02-010000-00-00NoNoCurrent