FDA.reportPublic FDA data

Candesartan Cilexetil and Hydrochlorothiazide

Product NDC
33342-133
11-digit product format
333420133
Labeler code
33342
Product ID
33342-133_07873250-a90d-4e06-bfa8-a4202794791d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan Cilexetil and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204100
Marketing category
ANDA
Marketing start
2015-03-07
Substance
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active strength
32; 25 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 1.

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
A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-27
A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-27
A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204100-001AB
A204100-002AB
A204100-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204100-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2015-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204100-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2015-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204100-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2015-02-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204100-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204100-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204100-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204100-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204100-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204100-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204100-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204100-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204100-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204100-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204100-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204100-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204100-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204100-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204100-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204100-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204100-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204100-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204100-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204100-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204100-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204100-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204100-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204100-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204100-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204100-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204100-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204100-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204100-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204100-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204100-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204100-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204100-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204100-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204100-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204100-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204100-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204100-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204100-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204100-001AB18072bd15b7f6…

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
HYDROCHLOROTHIAZIDE25 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
76630807-9717-44be-946d-756038cf677eAvailable 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
33342-133-10Candesartan Cilexetil and Hydrochlorothiazide90 in 1 BOTTLETABLET909
33342-133-12Candesartan Cilexetil and Hydrochlorothiazide10 in 1 BLISTER PACKTABLET109
33342-133-12Candesartan Cilexetil and Hydrochlorothiazide10 in 1 CARTONTABLET109
33342-133-15Candesartan Cilexetil and Hydrochlorothiazide500 in 1 BOTTLETABLET5009
33342-133-51Candesartan Cilexetil and Hydrochlorothiazide300 in 1 BOTTLETABLET3009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-133-10EA - Each33342-1330e0ef98e-aed7-4673-b241-ff169f6beda612016-07-19
33342-133-15EA - Each33342-13323c5a021-388a-4f3f-857d-60f74809162512016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CANDESARTAN CILEXETILACTIVE INGREDIENTR85M2X0D68CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
CANDESARTANACTIVE MOIETYS8Q36MD2XXCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-133CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 5 package rows20221101_76630807-9717-44be-946d-756038cf677e.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 HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited76630807-9717-44be-946d-756038cf677e2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204100
application number: ANDA204100
ndc (product): 33342-133

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578325candesartan cilexetil 16 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN76630807-9717-44be-946d-756038cf677e9
578330candesartan cilexetil 32 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN76630807-9717-44be-946d-756038cf677e9
802749candesartan cilexetil 32 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN76630807-9717-44be-946d-756038cf677e9
578325candesartan cilexetil 16 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD76630807-9717-44be-946d-756038cf677e9
578330candesartan cilexetil 32 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD76630807-9717-44be-946d-756038cf677e9
802749candesartan cilexetil 32 MG / hydrochlorothiazide 25 MG Oral TabletSCD76630807-9717-44be-946d-756038cf677e9
578325candesartan cilexetil 16 MG / HCTZ 12.5 MG Oral TabletSY76630807-9717-44be-946d-756038cf677e9
578330candesartan cilexetil 32 MG / HCTZ 12.5 MG Oral TabletSY76630807-9717-44be-946d-756038cf677e9
802749candesartan cilexetil 32 MG / HCTZ 25 MG Oral TabletSY76630807-9717-44be-946d-756038cf677e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-133-103334201331090 TABLET in 1 BOTTLE (33342-133-10) 90 tablet2015-03-070000-00-00NoNoCurrent
33342-133-123334201331210 BLISTER PACK in 1 CARTON (33342-133-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2015-03-070000-00-00NoNoCurrent
33342-133-1533342013315500 TABLET in 1 BOTTLE (33342-133-15) 500 tablet2015-03-070000-00-00NoNoCurrent
33342-133-5133342013351300 TABLET in 1 BOTTLE (33342-133-51) 300 tablet2015-03-070000-00-00NoNoCurrent