FDA.reportPublic FDA data

Avapro

Product NDC
0024-5850
11-digit product format
000245850
Labeler code
0024
Product ID
0024-5850_cf3ca8df-5a3f-413d-a895-65685cc17313
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
irbesartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA020757
Marketing category
NDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
IRBESARTAN
Active strength
75 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
34942a29-de4f-d63c-7755-ba18fe1411a0Product name620180619
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0024-5850-302024-08-20C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-302024-08-20C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-302024-08-20C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-902024-08-20C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-902024-08-20C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-902024-08-20C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-302024-07-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-302024-07-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-302024-07-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-902024-07-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-902024-07-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-902024-07-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-302024-01-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-302024-01-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-302024-01-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-902024-01-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-902024-01-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997
0024-5850-902024-01-30C16284748780-11030e365-684f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5850-30EA - Each0024-585082d9dc9d-5c19-420a-b5c1-9c9a1828109512013-03-03
0024-5850-90EA - Each0024-585059094881-298c-4a80-b37b-c9169af4a7da12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
irbesartanACTIVE INGREDIENTJ0E2756Z7NAVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
irbesartanACTIVE MOIETYJ0E2756Z7NAVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48AVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOAVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
magnesium stearateINACTIVE INGREDIENT70097M6I30AVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
polyethylene glycol 3000INACTIVE INGREDIENTSA1B764746AVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5850AVAPRO (IRBESARTAN) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]18Legacy NDC20250515_7885b2a8-be4e-48ab-8113-4e6ab791eb98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153666Avapro 150 MG Oral TabletPSN7885b2a8-be4e-48ab-8113-4e6ab791eb9821
153667Avapro 300 MG Oral TabletPSN7885b2a8-be4e-48ab-8113-4e6ab791eb9821
200095irbesartan 150 MG Oral TabletPSN7885b2a8-be4e-48ab-8113-4e6ab791eb9821
200096irbesartan 300 MG Oral TabletPSN7885b2a8-be4e-48ab-8113-4e6ab791eb9821
153666irbesartan 150 MG Oral Tablet [Avapro]SBD7885b2a8-be4e-48ab-8113-4e6ab791eb9821
153667irbesartan 300 MG Oral Tablet [Avapro]SBD7885b2a8-be4e-48ab-8113-4e6ab791eb9821
200095irbesartan 150 MG Oral TabletSCD7885b2a8-be4e-48ab-8113-4e6ab791eb9821
200096irbesartan 300 MG Oral TabletSCD7885b2a8-be4e-48ab-8113-4e6ab791eb9821
153666Avapro 150 MG Oral TabletSY7885b2a8-be4e-48ab-8113-4e6ab791eb9821
153667Avapro 300 MG Oral TabletSY7885b2a8-be4e-48ab-8113-4e6ab791eb9821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0024-5850-900002458509090 TABLET, FILM COATED in 1 BOTTLE (0024-5850-90) 2013-01-010000-00-00NoNoCurrent