FDA.reportPublic FDA data

Candesartan Cilexetil and Hydrochlorothiazide

Product NDC
0378-3001
11-digit product format
003783001
Labeler code
0378
Product ID
0378-3001_b308024b-d9c2-4b12-ac28-cb2e295ab1bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
candesartan cilexetil and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090704
Marketing category
ANDA
Marketing start
2012-12-04
Marketing end
2027-02-28
Substance
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active strength
16; 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
Current FDA listing
Yes

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 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
A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-04
A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-04
A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090704-001AB
A090704-002AB
A090704-003AB

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 UTC2026-02A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090704-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2012-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090704-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2012-12-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090704-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2012-12-048072bd15b7f6…

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 UTC2026-02A090704-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090704-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090704-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090704-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090704-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090704-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090704-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090704-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090704-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090704-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090704-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090704-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090704-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090704-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090704-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090704-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090704-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090704-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090704-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090704-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090704-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090704-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090704-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090704-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090704-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090704-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090704-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090704-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090704-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090704-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090704-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090704-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090704-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090704-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090704-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090704-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090704-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090704-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090704-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090704-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Candesartan Cilexetil and Hydrochlorothiazide

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANDESARTAN CILEXETIL16 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
f3c4f7ed-e667-4528-a675-b032c2a4425dAvailable 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
0378-3001-77Candesartan Cilexetil and Hydrochlorothiazide90 in 1 BOTTLE, PLASTICTABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3001-05EA - Each0378-300116d8ffce-7375-4ecd-acd7-85b55debe93c12013-02-13
0378-3001-77EA - Each0378-3001fc1e19f9-2b32-49e7-adb5-3452348b1f3f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CANDESARTAN CILEXETILACTIVE INGREDIENTR85M2X0D68CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
CANDESARTANACTIVE MOIETYS8Q36MD2XXCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 1 package rows20250117_f3c4f7ed-e667-4528-a675-b032c2a4425d.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 HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.f3c4f7ed-e667-4528-a675-b032c2a4425d2020-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090704
application number: ANDA090704
ndc (product): 0378-3001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578325candesartan cilexetil 16 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNf3c4f7ed-e667-4528-a675-b032c2a4425d15
578330candesartan cilexetil 32 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNf3c4f7ed-e667-4528-a675-b032c2a4425d15
802749candesartan cilexetil 32 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNf3c4f7ed-e667-4528-a675-b032c2a4425d15
578325candesartan cilexetil 16 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDf3c4f7ed-e667-4528-a675-b032c2a4425d15
578330candesartan cilexetil 32 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDf3c4f7ed-e667-4528-a675-b032c2a4425d15
802749candesartan cilexetil 32 MG / hydrochlorothiazide 25 MG Oral TabletSCDf3c4f7ed-e667-4528-a675-b032c2a4425d15
578325candesartan cilexetil 16 MG / HCTZ 12.5 MG Oral TabletSYf3c4f7ed-e667-4528-a675-b032c2a4425d15
578330candesartan cilexetil 32 MG / HCTZ 12.5 MG Oral TabletSYf3c4f7ed-e667-4528-a675-b032c2a4425d15
802749candesartan cilexetil 32 MG / HCTZ 25 MG Oral TabletSYf3c4f7ed-e667-4528-a675-b032c2a4425d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3001-0500378300105500 TABLET in 1 BOTTLE, PLASTIC (0378-3001-05) 500 tablet2012-12-042021-07-31NoNoCurrent
0378-3001-770037830017790 TABLET in 1 BOTTLE, PLASTIC (0378-3001-77) 90 tablet2012-12-042027-02-28NoNoCurrent