FDA.reportPublic FDA data

Irbesartan and Hydrochlorothiazide

Product NDC
65862-630
Requested package NDC
65862-630-30
11-digit product format
658620630
Labeler code
65862
Product ID
65862-630_6f7c3d7b-9b7c-447e-8763-f68a55ce4b91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203630
Marketing category
ANDA
Marketing start
2013-02-22
Substance
IRBESARTAN; HYDROCHLOROTHIAZIDE
Active strength
300; 12.5 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

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
A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;150MGTABLET / ORALAB2013-02-22
A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN12.5MG;300MGTABLET / ORALAB2013-02-22
A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTAN25MG;300MGTABLET / ORALAB2016-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203630-001AB
A203630-002AB
A203630-003AB

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 22:38:342026-08A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-3184e616aacf4f…
2026-08-18 06:07:402026-07A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203630-002IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;300MGTABLET / ORALAB2013-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203630-003IRBESARTAN AND HYDROCHLOROTHIAZIDE25MG;300MGTABLET / ORALAB2016-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203630-001IRBESARTAN AND HYDROCHLOROTHIAZIDE12.5MG;150MGTABLET / ORALAB2013-02-22301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203630-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203630-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203630-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A203630-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203630-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203630-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203630-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203630-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203630-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203630-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203630-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203630-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203630-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203630-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203630-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203630-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203630-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203630-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203630-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203630-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203630-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203630-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203630-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203630-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203630-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203630-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203630-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203630-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203630-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203630-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203630-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203630-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203630-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203630-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203630-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203630-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203630-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203630-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203630-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203630-001AB1301d65b070ca…

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
IRBESARTAN300 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310792Internal RxNorm lookup
310793Internal RxNorm lookup
485471Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
466dd0d2-9815-4c3e-b66b-d0732b3ba8e9Available 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
65862-630-05Irbesartan and Hydrochlorothiazide500 in 1 BOTTLETABLET, FILM COATED50014
65862-630-30Irbesartan and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3014
65862-630-90Irbesartan and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9014
65862-630-99Irbesartan and Hydrochlorothiazide1000 in 1 BOTTLETABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-630-30EA - Each65862-63048b013c1-2ba3-4727-a040-059ecd47b9f612026-03-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
IRBESARTANACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
IRBESARTANACTIVE MOIETYJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-630IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12Current NDC, Legacy NDC, 4 package rows20240518_466dd0d2-9815-4c3e-b66b-d0732b3ba8e9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited466dd0d2-9815-4c3e-b66b-d0732b3ba8e92025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203630
application number: ANDA203630
ndc (package): 65862-630-30
ndc (product): 65862-630
ndc11 (package): 65862063030

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN466dd0d2-9815-4c3e-b66b-d0732b3ba8e914
310793irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN466dd0d2-9815-4c3e-b66b-d0732b3ba8e914
485471irbesartan 300 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN466dd0d2-9815-4c3e-b66b-d0732b3ba8e914
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD466dd0d2-9815-4c3e-b66b-d0732b3ba8e914
310793hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral TabletSCD466dd0d2-9815-4c3e-b66b-d0732b3ba8e914
485471hydrochlorothiazide 25 MG / irbesartan 300 MG Oral TabletSCD466dd0d2-9815-4c3e-b66b-d0732b3ba8e914
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY466dd0d2-9815-4c3e-b66b-d0732b3ba8e914
310793HCTZ 12.5 MG / irbesartan 300 MG Oral TabletSY466dd0d2-9815-4c3e-b66b-d0732b3ba8e914
485471HCTZ 25 MG / irbesartan 300 MG Oral TabletSY466dd0d2-9815-4c3e-b66b-d0732b3ba8e914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-630-306586206303030 TABLET, FILM COATED in 1 BOTTLE (65862-630-30) 2013-02-220000-00-00NoNoCurrent