FDA.reportPublic FDA data

Avalide

Product NDC
0024-5856
11-digit product format
000245856
Labeler code
0024
Product ID
0024-5856_5f9089ce-2d9c-4077-8774-acd86b5eff4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
irbesartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA020758
Marketing category
NDA
Marketing start
2013-01-01
Substance
HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength
12.5; 300 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Avalide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
IRBESARTAN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N, 0J48LPH2TH
Rxcui310792, 310793, 823934, 823938

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
34942a29-de4f-d63c-7755-ba18fe1411a0Product name620180619
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0024-5856-302024-08-20C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-302024-08-20C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-902024-08-20C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-902024-08-20C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-302024-07-30C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-302024-07-30C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-902024-07-30C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-902024-07-30C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-302024-01-30C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-302024-01-30C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-902024-01-30C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997
0024-5856-902024-01-30C16284748780-11030e365-0333-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5856-30Avalide30 in 1 BOTTLETABLET, FILM COATED3024
0024-5856-90Avalide90 in 1 BOTTLETABLET, FILM COATED9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5856-30EA - Each0024-585601c4fb3a-44b7-4545-a190-d6ea69a538fc12013-03-03
0024-5856-90EA - Each0024-5856923c67eb-1230-43b6-a8f3-847eb18e26cd12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydrochlorothiazideACTIVE INGREDIENT0J48LPH2THAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
irbesartanACTIVE INGREDIENTJ0E2756Z7NAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
hydrochlorothiazideACTIVE MOIETY0J48LPH2THAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
irbesartanACTIVE MOIETYJ0E2756Z7NAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
carnauba waxINACTIVE INGREDIENTR12CBM0EIZAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
ferric oxide redINACTIVE INGREDIENT1K09F3G675AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
magnesium stearateINACTIVE INGREDIENT70097M6I30AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5856AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22Current NDC, Legacy NDC, 2 package rows20250519_0d91895e-c869-4b33-9b83-d55c1ad6317e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
823934Avalide 150 MG / 12.5 MG Oral TabletPSN0d91895e-c869-4b33-9b83-d55c1ad6317e24
823938Avalide 300 MG / 12.5 MG Oral TabletPSN0d91895e-c869-4b33-9b83-d55c1ad6317e24
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN0d91895e-c869-4b33-9b83-d55c1ad6317e24
310793irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN0d91895e-c869-4b33-9b83-d55c1ad6317e24
823934hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet [Avalide]SBD0d91895e-c869-4b33-9b83-d55c1ad6317e24
823938hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral Tablet [Avalide]SBD0d91895e-c869-4b33-9b83-d55c1ad6317e24
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD0d91895e-c869-4b33-9b83-d55c1ad6317e24
310793hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral TabletSCD0d91895e-c869-4b33-9b83-d55c1ad6317e24
823934Avalide 150/12.5 (irbesartan / HCTZ) Oral TabletSY0d91895e-c869-4b33-9b83-d55c1ad6317e24
823934Avalide 150/12.5 Oral TabletSY0d91895e-c869-4b33-9b83-d55c1ad6317e24
823938Avalide 300/12.5 (irbesartan / HCTZ) Oral TabletSY0d91895e-c869-4b33-9b83-d55c1ad6317e24
823938Avalide 300/12.5 Oral TabletSY0d91895e-c869-4b33-9b83-d55c1ad6317e24
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY0d91895e-c869-4b33-9b83-d55c1ad6317e24
823934HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet [Avalide]SY0d91895e-c869-4b33-9b83-d55c1ad6317e24
310793HCTZ 12.5 MG / irbesartan 300 MG Oral TabletSY0d91895e-c869-4b33-9b83-d55c1ad6317e24
823938HCTZ 12.5 MG / irbesartan 300 MG Oral Tablet [Avalide]SY0d91895e-c869-4b33-9b83-d55c1ad6317e24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0024-5856-300002458563030 TABLET, FILM COATED in 1 BOTTLE (0024-5856-30) 2013-01-010000-00-00NoNoCurrent
0024-5856-900002458569090 in 1 BOTTLEHistorical