Home NDC 70518-2720 Candesartan Cilexetil and Hydrochlorothiazide
Product NDC 70518-2720
11-digit product format 705182720
Labeler code 70518
Product ID 70518-2720_d6e70b03-c455-1fb3-e053-2995a90a62dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Candesartan Cilexetil and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA021093
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-05-01
Marketing end 0000-00-00
Substance CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active strength 32 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-2720-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-2720-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-2720-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-2720-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-2720-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-2720-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-2720-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-2720-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-2720-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-2720-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-2720-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-2720-0 557ba5c1ecfa…9c80585c8c6e…
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.
FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-2720-0 70518272000 90 TABLET in 1 BOTTLE, PLASTIC (70518-2720-0) 90 tablet 2020-05-01 0000-00-00 No No Current