Home NDC 62559-688 Candesartan cilexetil
Product NDC 62559-688
11-digit product format 625590688
Labeler code 62559
Product ID 62559-688_9cfa9177-a7c4-416c-9328-dfdb4f27bfde
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Candesartan cilexetil
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA020838
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-03-15
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 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020838-001 ATACAND CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB RLD 1998-06-04 N020838-002 ATACAND CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB RLD 1998-06-04 N020838-003 ATACAND CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB RLD 1998-06-04 N020838-004 ATACAND CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB RLD, RS 1998-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020838-001 ATACAND 4MG TABLET / ORAL AB RLD 1998-06-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020838-002 ATACAND 8MG TABLET / ORAL AB RLD 1998-06-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020838-003 ATACAND 16MG TABLET / ORAL AB RLD 1998-06-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020838-004 ATACAND 32MG TABLET / ORAL AB RLD, RS 1998-06-04 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Candesartan cilexetil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CANDESARTAN CILEXETIL 16 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R85M2X0D68 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153822 Internal RxNorm lookup 153823 Internal RxNorm lookup 577776 Internal RxNorm lookup 639537 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62559-688-99 Candesartan cilexetil 50000 in 1 BOX TABLET 50000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-688 CANDESARTAN CILEXETIL TABLET [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20240316_4621249c-1f44-4d95-8513-a1a2b1859e41.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Candesartan cilexetil CANDESARTAN CILEXETIL Golden State Medical Supply, Inc. 15601654-76da-04cf-e063-6394a90a2cb5 2026-01-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020838 application number: NDA020838 ATACAND CANDESARTAN CILEXETIL ANI Pharmaceuticals, Inc. 94a59260-d2b6-464a-b5b9-bbc599e57e10 2025-12-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020838 application number: NDA020838 Candesartan cilexetil CANDESARTAN CILEXETIL ANI Pharmaceuticals, Inc. 4621249c-1f44-4d95-8513-a1a2b1859e41 2025-12-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020838 application number: NDA020838 ndc (product): 62559-688
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62559-688-99 62559068899 50000 TABLET in 1 BOX (62559-688-99) 50000 tablet 2024-03-15 No No Current