FDA.reportPublic FDA data

candesartan cilexetil and hydrochlorothiazide

Product NDC
70771-1326
11-digit product format
707711326
Labeler code
70771
Product ID
70771-1326_2b38d778-d732-4a7b-bb34-b426a14e10bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
candesartan cilexetil and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203466
Marketing category
ANDA
Marketing start
2018-04-14
Substance
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active strength
32; 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 44.

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
A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27
A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27
A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203466-001AB
A203466-002AB
A203466-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27c2088c7a36db…
2026-10-15 13:18:302026-09A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27c2088c7a36db…
2026-10-15 13:18:302026-09A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27c2088c7a36db…
2026-09-14 22:38:342026-08A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-2784e616aacf4f…
2026-09-14 22:38:342026-08A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-2784e616aacf4f…
2026-09-14 22:38:342026-08A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-2784e616aacf4f…
2026-08-18 06:07:402026-07A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-2779d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203466-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203466-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203466-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203466-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203466-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203466-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203466-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203466-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203466-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203466-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203466-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203466-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203466-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203466-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203466-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203466-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203466-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203466-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203466-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203466-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203466-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203466-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203466-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203466-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203466-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203466-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203466-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203466-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203466-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203466-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203466-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203466-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203466-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203466-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203466-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203466-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203466-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203466-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203466-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A203466-002AB1c0c555d07b60…

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
candesartan cilexetil and hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANDESARTAN CILEXETIL32 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
R85M2X0D68Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
578325Internal RxNorm lookup
578330Internal RxNorm lookup
802749Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb328bc1-5738-4620-b2b3-442e98388a86Available 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
03f056e9-4354-02cc-6010-79c6c9eaac0aProduct name620250521
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
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
70771-1326-0candesartan cilexetil and hydrochlorothiazide1000 in 1 BOTTLETABLET10005
70771-1326-1candesartan cilexetil and hydrochlorothiazide100 in 1 BOTTLETABLET1005
70771-1326-2candesartan cilexetil and hydrochlorothiazide10 in 1 BLISTER PACKTABLET105
70771-1326-3candesartan cilexetil and hydrochlorothiazide30 in 1 BOTTLETABLET305
70771-1326-4candesartan cilexetil and hydrochlorothiazide10 in 1 CARTONTABLET105
70771-1326-9candesartan cilexetil and hydrochlorothiazide90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1326CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 6 package rows20241113_cb328bc1-5738-4620-b2b3-442e98388a86.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
candesartan cilexetil and hydrochlorothiazideCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limitedcb328bc1-5738-4620-b2b3-442e98388a862024-11-11Exact identifier
application applno (ANDA): 203466
application number: ANDA203466
ndc (product): 70771-1326

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578325candesartan cilexetil 16 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNcb328bc1-5738-4620-b2b3-442e98388a865
578330candesartan cilexetil 32 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNcb328bc1-5738-4620-b2b3-442e98388a865
802749candesartan cilexetil 32 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNcb328bc1-5738-4620-b2b3-442e98388a865
578325candesartan cilexetil 16 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDcb328bc1-5738-4620-b2b3-442e98388a865
578330candesartan cilexetil 32 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDcb328bc1-5738-4620-b2b3-442e98388a865
802749candesartan cilexetil 32 MG / hydrochlorothiazide 25 MG Oral TabletSCDcb328bc1-5738-4620-b2b3-442e98388a865
578325candesartan cilexetil 16 MG / HCTZ 12.5 MG Oral TabletSYcb328bc1-5738-4620-b2b3-442e98388a865
578330candesartan cilexetil 32 MG / HCTZ 12.5 MG Oral TabletSYcb328bc1-5738-4620-b2b3-442e98388a865
802749candesartan cilexetil 32 MG / HCTZ 25 MG Oral TabletSYcb328bc1-5738-4620-b2b3-442e98388a865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1326-0707711326001000 TABLET in 1 BOTTLE (70771-1326-0) 1000 tablet2018-04-140000-00-00NoNoCurrent
70771-1326-170771132601100 TABLET in 1 BOTTLE (70771-1326-1) 100 tablet2018-04-140000-00-00NoNoCurrent
70771-1326-27077113260210 in 1 BLISTER PACKHistorical
70771-1326-37077113260330 TABLET in 1 BOTTLE (70771-1326-3) 30 tablet2018-04-140000-00-00NoNoCurrent
70771-1326-47077113260410 BLISTER PACK in 1 CARTON (70771-1326-4) / 10 TABLET in 1 BLISTER PACK (70771-1326-2) 10 blister pack2018-04-140000-00-00NoNoCurrent
70771-1326-97077113260990 TABLET in 1 BOTTLE (70771-1326-9) 90 tablet2018-04-140000-00-00NoNoCurrent