Irbesartan and Hydrochlorothiazide

Product NDC
71335-2099
11-digit product format
713352099
Labeler code
71335
Product ID
71335-2099_cab146b8-2697-4073-a106-931e7a183bf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;150MGTABLET / ORALAB2014-05-09
A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;300MGTABLET / ORALAB2014-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203072-001AB
A203072-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-0984e616aacf4f…
2026-09-14 22:38:342026-08A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-0984e616aacf4f…
2026-08-18 06:07:402026-07A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203072-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2014-05-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203072-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2014-05-0974a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203072-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203072-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A203072-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203072-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203072-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203072-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203072-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203072-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203072-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203072-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203072-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203072-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203072-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203072-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203072-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203072-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203072-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203072-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203072-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203072-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203072-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203072-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203072-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203072-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203072-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203072-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203072-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203072-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203072-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203072-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203072-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203072-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203072-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203072-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203072-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203072-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203072-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203072-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203072-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203072-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J0E2756Z7NInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310792Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85494404-484c-45a1-8487-f9eb2a76490dAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2099-1Irbesartan and Hydrochlorothiazide30 in 1 BOTTLETABLET30102
71335-2099-2Irbesartan and Hydrochlorothiazide90 in 1 BOTTLETABLET90102
71335-2099-3Irbesartan and Hydrochlorothiazide28 in 1 BOTTLETABLET28102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2099IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20231116_85494404-484c-45a1-8487-f9eb2a76490d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.88aaa2a1-13be-4f56-ace6-66e8990280072026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203072
application number: ANDA203072
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack85494404-484c-45a1-8487-f9eb2a76490d2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203072
application number: ANDA203072
ndc (product): 71335-2099
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLC72fa8cd4-bc2a-4a7d-8feb-2d60e077d8012026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203072
application number: ANDA203072
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53ce6e4f-db3a-4789-8bef-1e459fa78b792026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203072
application number: ANDA203072
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPc7ce5a69-1e07-4d52-b815-ce64ac3731ac2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203072
application number: ANDA203072

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2099-17133520990130 TABLET in 1 BOTTLE (71335-2099-1) 30 tablet2022-06-060000-00-00NoNoCurrent
71335-2099-27133520990290 TABLET in 1 BOTTLE (71335-2099-2) 90 tablet2022-06-060000-00-00NoNoCurrent
71335-2099-37133520990328 TABLET in 1 BOTTLE (71335-2099-3) 28 tablet2022-06-060000-00-00NoNoCurrent