FDA.reportPublic FDA data

Irbesartan and Hydrochlorothiazide

Product NDC
0093-8238
Requested package NDC
0093-8238-56
11-digit product format
000938238
Labeler code
0093
Product ID
0093-8238_af80b0d1-ba9d-4d3c-849c-6c7c1a7cfade
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077369
Marketing category
ANDA
Marketing start
2013-01-24
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0093-82380093-8238-56DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;150MGTABLET / ORALAB2012-03-30
A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;300MGTABLET / ORALAB2012-03-30
A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN25MG;300MGTABLET / ORAL2012-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077369-001AB
A077369-002AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-3084e616aacf4f…
2026-08-18 06:07:402026-07A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077369-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2012-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077369-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORAL2012-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077369-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2012-03-30301d65b070ca…

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 22:38:342026-08A077369-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077369-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A077369-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077369-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077369-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077369-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077369-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077369-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077369-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077369-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077369-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077369-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077369-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077369-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077369-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077369-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077369-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077369-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077369-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077369-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077369-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077369-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077369-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077369-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077369-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077369-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077369-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077369-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077369-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077369-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077369-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077369-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077369-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077369-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077369-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077369-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077369-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077369-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077369-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077369-002AB174a2ff9319b5…

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
0J48LPH2THInternal UNII lookup
J0E2756Z7NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310792Internal RxNorm lookup
310793Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
83f4acc1-697a-4770-b554-1b9a8fb5de74Available 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-8238-56Irbesartan and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3016
0093-8238-98Irbesartan and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8238-56EA - Each0093-82383e7ff237-1c22-4aaf-b58d-5c39b20f667012013-02-13
0093-8238-98EA - Each0093-8238ec4bba1f-afa7-457c-80eb-819f722b7a1a12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
IRBESARTANACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
IRBESARTANACTIVE MOIETYJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
IRBESARTANACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
IRBESARTANACTIVE MOIETYJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
Hypromellose 2910 (5 Mpa.s)INACTIVE INGREDIENTR75537T0T4IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
Polyethylene Glycol 6000INACTIVE INGREDIENT30IQX730WEIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8238IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 2 package rows20211203_83f4acc1-697a-4770-b554-1b9a8fb5de74.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5eabb13d-f6fd-4091-9909-c4f0c59222892026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077369
application number: ANDA077369
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5029c9f7-6233-4a6f-ace9-2268cc8e286d2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077369
application number: ANDA077369
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.83f4acc1-697a-4770-b554-1b9a8fb5de742026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077369
application number: ANDA077369
ndc (package): 0093-8238-56
ndc (product): 0093-8238
ndc11 (package): 00093823856
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPc5f26357-40f3-49f4-99f2-845a8dda5f392019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077369
application number: ANDA077369

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN5029c9f7-6233-4a6f-ace9-2268cc8e286d101
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD5029c9f7-6233-4a6f-ace9-2268cc8e286d101
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY5029c9f7-6233-4a6f-ace9-2268cc8e286d101
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN83f4acc1-697a-4770-b554-1b9a8fb5de7416
310793irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN83f4acc1-697a-4770-b554-1b9a8fb5de7416
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD83f4acc1-697a-4770-b554-1b9a8fb5de7416
310793hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral TabletSCD83f4acc1-697a-4770-b554-1b9a8fb5de7416
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY83f4acc1-697a-4770-b554-1b9a8fb5de7416
310793HCTZ 12.5 MG / irbesartan 300 MG Oral TabletSY83f4acc1-697a-4770-b554-1b9a8fb5de7416
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN5eabb13d-f6fd-4091-9909-c4f0c59222894
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD5eabb13d-f6fd-4091-9909-c4f0c59222894
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY5eabb13d-f6fd-4091-9909-c4f0c59222894
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc5f26357-40f3-49f4-99f2-845a8dda5f393
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCDc5f26357-40f3-49f4-99f2-845a8dda5f393
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSYc5f26357-40f3-49f4-99f2-845a8dda5f393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-8238-560009382385630 TABLET, FILM COATED in 1 BOTTLE (0093-8238-56) 2013-01-240000-00-00NoNoCurrent