FDA.reportPublic FDA data

Irbesartan and Hydrochlorothiazide

Product NDC
43547-330
11-digit product format
435470330
Labeler code
43547
Product ID
43547-330_3e6f512c-8ff3-40b0-bcd3-9bf9bf26a112
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA203072
Marketing category
ANDA
Marketing start
2014-03-01
Substance
HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength
12.5; 150 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Irbesartan and Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
IRBESARTAN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N, 0J48LPH2TH

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product 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
43547-330-032020-04-23C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-032020-04-23C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-092020-04-23C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-092020-04-23C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-502020-04-23C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-502020-04-23C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-032020-01-31C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-032020-01-31C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-092020-01-31C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-092020-01-31C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-502020-01-31C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
43547-330-502020-01-31C16284748780-19d75b9d0-209b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-330-03Irbesartan and Hydrochlorothiazide30 in 1 BOTTLETABLET3011
43547-330-09Irbesartan and Hydrochlorothiazide90 in 1 BOTTLETABLET9011
43547-330-50Irbesartan and Hydrochlorothiazide500 in 1 BOTTLETABLET50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-330-03EA - Each43547-330c9d870ee-ac1f-4f90-99a5-264ab3548b6b12014-06-03
43547-330-09EA - Each43547-330013f85f2-e550-48fa-9f82-cf7b3e11b99812014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
IRBESARTANACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
IRBESARTANACTIVE MOIETYJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-330IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC]9Current NDC, Legacy NDC, 3 package rows20250426_72fa8cd4-bc2a-4a7d-8feb-2d60e077d801.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN85494404-484c-45a1-8487-f9eb2a76490d103
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD85494404-484c-45a1-8487-f9eb2a76490d103
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY85494404-484c-45a1-8487-f9eb2a76490d103
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN53ce6e4f-db3a-4789-8bef-1e459fa78b79102
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD53ce6e4f-db3a-4789-8bef-1e459fa78b79102
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY53ce6e4f-db3a-4789-8bef-1e459fa78b79102
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN72fa8cd4-bc2a-4a7d-8feb-2d60e077d80111
310793irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN72fa8cd4-bc2a-4a7d-8feb-2d60e077d80111
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD72fa8cd4-bc2a-4a7d-8feb-2d60e077d80111
310793hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral TabletSCD72fa8cd4-bc2a-4a7d-8feb-2d60e077d80111
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY72fa8cd4-bc2a-4a7d-8feb-2d60e077d80111
310793HCTZ 12.5 MG / irbesartan 300 MG Oral TabletSY72fa8cd4-bc2a-4a7d-8feb-2d60e077d80111
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc7ce5a69-1e07-4d52-b815-ce64ac3731ac4
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCDc7ce5a69-1e07-4d52-b815-ce64ac3731ac4
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSYc7ce5a69-1e07-4d52-b815-ce64ac3731ac4
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN89b8360b-2e30-4ad1-b7b6-df0866f58a221
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD89b8360b-2e30-4ad1-b7b6-df0866f58a221
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY89b8360b-2e30-4ad1-b7b6-df0866f58a221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-330-034354703300330 TABLET in 1 BOTTLE (43547-330-03) 30 tablet2014-03-010000-00-00NoNoCurrent
43547-330-094354703300990 TABLET in 1 BOTTLE (43547-330-09) 90 tablet2014-03-010000-00-00NoNoCurrent
43547-330-5043547033050500 TABLET in 1 BOTTLE (43547-330-50) 500 tablet2014-03-010000-00-00NoNoCurrent