Home NDC 68382-928-05 Amlodipine and olmesartan medoxomil
Product NDC 68382-928
Requested package NDC 68382-928-05
11-digit product format 683820928
Labeler code 68382
Product ID 68382-928_cf71e29b-40b3-470b-b837-5a4bdd6f9409
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine and olmesartan medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA207771
Marketing category ANDA
Marketing start 2018-01-04
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength 10 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68382-928 68382-928-05 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-928 68382-928-05 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22
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 · 172 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 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207771-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-09-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207771-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-09-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207771-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-09-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207771-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-09-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68382-928-05 68382092805 500 TABLET, FILM COATED in 1 BOTTLE (68382-928-05) 2018-01-04 0000-00-00 No No Current