Home NDC 63629-3377-3 ATACAND HCT
Product NDC 63629-3377
Requested package NDC 63629-3377-3
11-digit product format 636293377
Labeler code 63629
Product ID 63629-3377_10548eb6-bfd4-4083-9bcf-6831ad0dd210
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Candesartan cilexetil and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA021093
Marketing category NDA
Marketing start 2000-09-28
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 2020-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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.
DailyMed Socrata Ingredients# 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 63629-3377-3 63629337703 90 TABLET in 1 BOTTLE (63629-3377-3) 90 tablet 2007-02-23 0000-00-00 No No Current