Candesartan cilexetil

Product NDC
68382-193
Requested package NDC
68382-193-10
11-digit product format
683820193
Labeler code
68382
Product ID
68382-193_da3d5c58-fa7e-45a0-87fe-baa52e23a3fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA091390
Marketing category
ANDA
Marketing start
2018-02-22
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68382-19368382-193-10DDiscontinued 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 · 11 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…

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
A091390-001CANDESARTAN CILEXETILCANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-23
A091390-002CANDESARTAN CILEXETILCANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-23
A091390-003CANDESARTAN CILEXETILCANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-23
A091390-004CANDESARTAN CILEXETILCANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091390-001AB
A091390-002AB
A091390-003AB
A091390-004AB

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 UTC2026-02A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORAL2017-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORAL2017-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORAL2017-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORAL2017-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-23d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091390-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091390-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091390-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091390-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091390-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091390-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091390-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091390-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091390-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091390-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091390-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091390-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091390-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091390-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091390-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091390-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091390-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091390-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091390-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091390-004AB1b8a1b40f171c…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091390-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091390-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091390-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091390-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091390-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091390-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091390-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091390-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091390-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091390-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091390-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091390-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091390-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091390-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091390-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091390-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091390-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091390-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091390-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091390-004AB179d66fd596c7…

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 cilexetilCANDESARTAN CILEXETILZydus Lifesciences Limited26df3269-3682-4ce0-be81-8c029254b5a82025-12-24Exact identifier
application applno (ANDA): 091390
application number: ANDA091390

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-193-10683820193101000 TABLET in 1 BOTTLE (68382-193-10) 1000 tablet2018-02-220000-00-00NoNoCurrent