Home NDC 68382-192-06 Candesartan cilexetil
Product NDC 68382-192
Requested package NDC 68382-192-06
11-digit product format 683820192
Labeler code 68382
Product ID 68382-192_da3d5c58-fa7e-45a0-87fe-baa52e23a3fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Candesartan cilexetil
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA091390
Marketing category ANDA
Marketing start 2018-02-22
Marketing end 0000-00-00
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 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 · 11 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…
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 A091390-001 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 A091390-002 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 A091390-003 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 A091390-004 CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23
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 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL 2017-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL 2017-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL 2017-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL 2017-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091390-001 CANDESARTAN CILEXETIL 4MG TABLET / ORAL AB 2017-08-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091390-002 CANDESARTAN CILEXETIL 8MG TABLET / ORAL AB 2017-08-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091390-003 CANDESARTAN CILEXETIL 16MG TABLET / ORAL AB 2017-08-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091390-004 CANDESARTAN CILEXETIL 32MG TABLET / ORAL AB 2017-08-23 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
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 68382-192-06 68382019206 30 TABLET in 1 BOTTLE (68382-192-06) 30 tablet 2018-02-22 0000-00-00 No No Current