Irbesartan

Product NDC
0955-1041
11-digit product format
009551041
Labeler code
0955
Product ID
0955-1041_5236a5fb-5969-4cc2-bcd1-400e261fbf46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
irbesartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Winthrop U.S.
Application
NDA020757
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-09-30
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1041-30EA - Each0955-1041ab20b0d2-2ef5-4a30-a0ab-068e9a713a2212012-07-24
0955-1041-90EA - Each0955-1041cad9cffd-0ee2-404a-b0a7-2918205be77e12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0955-1041-900095510419090 TABLET, FILM COATED in 1 BOTTLE (0955-1041-90) 2019-09-300000-00-00NoNoCurrent