Home NDC 62559-651 ATACAND HCT
Product NDC 62559-651
11-digit product format 625590651
Labeler code 62559
Product ID 62559-651_512f014c-894d-43ff-96a6-1ff05bc476e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Candesartan Cilexetil and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA021093
Marketing category NDA
Marketing start 2018-10-01
Substance CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active strength 32; 12.5 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021093-001 ATACAND HCT CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 N021093-002 ATACAND HCT CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 N021093-003 ATACAND HCT CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021093-002 ATACAND HCT 32MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021093-003 ATACAND HCT 32MG;25MG TABLET / ORAL AB RLD, RS 2008-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021093-001 ATACAND HCT 16MG;12.5MG TABLET / ORAL AB RLD 2000-09-05 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ATACAND HCT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CANDESARTAN CILEXETIL 32 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup R85M2X0D68 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 578325 Internal RxNorm lookup 578330 Internal RxNorm lookup 802749 Internal RxNorm lookup 805855 Internal RxNorm lookup 805859 Internal RxNorm lookup 805863 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 62559-651-90 ATACAND HCT 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-651 ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20200508_d91152c4-66ba-466f-b4f9-0da628d42b1d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62559-651-90 62559065190 90 TABLET in 1 BOTTLE (62559-651-90) 90 tablet 2018-10-01 0000-00-00 No No Current