Candesartan cilexetil

Product NDC
72578-158
11-digit product format
725780158
Labeler code
72578
Product ID
72578-158_4093b082-6e7b-4dea-b659-69b0b9bc84e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA091390
Marketing category
ANDA
Marketing start
2026-09-07
Substance
CANDESARTAN CILEXETIL
Active strength
8 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
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 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-2384e616aacf4f…
2026-09-14 22:38:342026-08A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-2384e616aacf4f…
2026-09-14 22:38:342026-08A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-2384e616aacf4f…
2026-09-14 22:38:342026-08A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-2384e616aacf4f…
2026-08-18 06:07:402026-07A091390-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2017-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A091390-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2017-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A091390-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2017-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A091390-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2017-08-23caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A091390-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A091390-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A091390-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A091390-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A091390-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091390-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091390-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091390-004AB1caaa826d4ba7…
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…

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANDESARTAN CILEXETIL8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R85M2X0D68Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
153822Internal RxNorm lookup
153823Internal RxNorm lookup
577776Internal RxNorm lookup
639537Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9da86c48-5911-4512-8c71-eca4a6418cf6Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candesartan cilexetilCANDESARTAN CILEXETILViona Pharmaceuticals Inc9da86c48-5911-4512-8c71-eca4a6418cf62026-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091390
application number: ANDA091390
ndc (product): 72578-158
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 startSampleExclude flagStatus
72578-158-067257801580630 TABLET in 1 BOTTLE (72578-158-06) 30 tablet2026-09-07NoNoCurrent
72578-158-167257801581690 TABLET in 1 BOTTLE (72578-158-16) 90 tablet2026-09-07NoNoCurrent