Candesartan

Product NDC
71335-3032
11-digit product format
713353032
Labeler code
71335
Product ID
71335-3032_eeef5a15-6a83-4012-aee3-486668b243a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203813
Marketing category
ANDA
Marketing start
2016-12-06
Substance
CANDESARTAN CILEXETIL
Active strength
16 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 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
A203813-001CANDESARTAN CILEXETILCANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-05
A203813-002CANDESARTAN CILEXETILCANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-05
A203813-003CANDESARTAN CILEXETILCANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-05
A203813-004CANDESARTAN CILEXETILCANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203813-001AB
A203813-002AB
A203813-003AB
A203813-004AB

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 UTC2026-02A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203813-001CANDESARTAN CILEXETIL4MGTABLET / ORALAB2016-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A203813-002CANDESARTAN CILEXETIL8MGTABLET / ORALAB2016-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A203813-003CANDESARTAN CILEXETIL16MGTABLET / ORALAB2016-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A203813-004CANDESARTAN CILEXETIL32MGTABLET / ORALAB2016-12-05d06236e962d9…

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 UTC2026-02A203813-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203813-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203813-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203813-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203813-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203813-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203813-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203813-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203813-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203813-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203813-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203813-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203813-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203813-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203813-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203813-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203813-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203813-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203813-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203813-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203813-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203813-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203813-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203813-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203813-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203813-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203813-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203813-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203813-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203813-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203813-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203813-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203813-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203813-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203813-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203813-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203813-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203813-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203813-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203813-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Candesartan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANDESARTAN CILEXETIL16 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7eb297cb-ef1b-44e0-a49d-03727100579eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
03f056e9-4354-02cc-6010-79c6c9eaac0aProduct name620250521
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3032-1Candesartan30 in 1 BOTTLETABLET301
71335-3032-2Candesartan90 in 1 BOTTLETABLET901

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
CandesartanCANDESARTANBryant Ranch Prepack7eb297cb-ef1b-44e0-a49d-03727100579e2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203813
application number: ANDA203813
ndc (product): 71335-3032
CandesartanCANDESARTANNorthStar RxLLC880f685f-be01-42f4-9e76-ebd1fcfb1f772025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203813
application number: ANDA203813
CandesartanCANDESARTANMacleods Pharmaceuticals Limited8ceb5658-b03c-475d-9ef0-2cd0645191d32022-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203813
application number: ANDA203813

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577776candesartan cilexetil 16 MG Oral TabletPSN7eb297cb-ef1b-44e0-a49d-03727100579e1
577776candesartan cilexetil 16 MG Oral TabletSCD7eb297cb-ef1b-44e0-a49d-03727100579e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3032-17133530320130 TABLET in 1 BOTTLE (71335-3032-1) 30 tablet2026-02-05NoNoCurrent
71335-3032-27133530320290 TABLET in 1 BOTTLE (71335-3032-2) 90 tablet2026-02-05NoNoCurrent