Home NDC 68382-195-01 candesartan cilexetil and hydrochlorothiazide
Product NDC 68382-195
Requested package NDC 68382-195-01
11-digit product format 683820195
Labeler code 68382
Product ID 68382-195_7750ee73-dc70-452f-87f1-f38216254e35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name candesartan cilexetil and hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA203466
Marketing category ANDA
Marketing start 2018-04-14
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 · 10 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27
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 · 129 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 2026-09-14 22:38:34 2026-08 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203466-002 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;12.5MG TABLET / ORAL AB 2017-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203466-003 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG TABLET / ORAL AB 2017-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203466-001 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 16MG;12.5MG TABLET / ORAL AB 2017-11-27 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 1 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 68382-195-01 68382019501 100 TABLET in 1 BOTTLE (68382-195-01) 100 tablet 2018-04-14 0000-00-00 No No Current