Candesartan cilexetil

Product NDC
60687-130
11-digit product format
606870130
Labeler code
60687
Product ID
60687-130_e64b400e-9db9-7fba-e053-2a95a90a8aac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
NDA020838
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-09-24
Marketing end
0000-00-00
Substance
CANDESARTAN CILEXETIL
Active strength
32 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60687-130DDiscontinued by firm2026-08-03
excluded productproduct60687-130DDiscontinued by firm2026-08-03
excluded packagepackage60687-13060687-130-21DDiscontinued by firm2026-08-03
excluded packagepackage60687-13060687-130-25DDiscontinued by firm2026-08-03

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60687-130-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60687-130-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60687-130-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60687-130-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60687-130-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60687-130-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60687-130-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60687-130-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60687-130-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60687-130-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60687-130-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60687-130-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60687-130-21557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020838-001ATACANDCANDESARTAN CILEXETIL4MGTABLET / ORALABRLD1998-06-04
N020838-002ATACANDCANDESARTAN CILEXETIL8MGTABLET / ORALABRLD1998-06-04
N020838-003ATACANDCANDESARTAN CILEXETIL16MGTABLET / ORALABRLD1998-06-04
N020838-004ATACANDCANDESARTAN CILEXETIL32MGTABLET / ORALABRLD, RS1998-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020838-001AB
N020838-002AB
N020838-003AB
N020838-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020838-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020838-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020838-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-130-25EA - Each60687-1304701ac2f-282f-441e-ba73-06e8a761b43612015-11-12
60687-130-95EA - Each60687-1308b7ef28c-328c-4428-8252-44a1be0faf0612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CANDESARTAN CILEXETILACTIVE INGREDIENTR85M2X0D68CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]1
CANDESARTANACTIVE MOIETYS8Q36MD2XXCANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]1
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-130CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]10Legacy NDC20241123_8d9a7eb7-fe06-4fd4-b6f2-1dd88d91838d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candesartan cilexetilCANDESARTAN CILEXETILGolden State Medical Supply, Inc.15601654-76da-04cf-e063-6394a90a2cb52026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020838
application number: NDA020838
ATACANDCANDESARTAN CILEXETILANI Pharmaceuticals, Inc.94a59260-d2b6-464a-b5b9-bbc599e57e102025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020838
application number: NDA020838
Candesartan cilexetilCANDESARTAN CILEXETILANI Pharmaceuticals, Inc.4621249c-1f44-4d95-8513-a1a2b1859e412025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020838
application number: NDA020838

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-130-256068701302530 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-130-25) > 1 TABLET in 1 BLISTER PACK (60687-130-95) 30 blister pack2015-09-240000-00-00NoNoCurrent