Home NDC 65597-110-30 Azor
Product NDC 65597-110
Requested package NDC 65597-110-30
11-digit product format 655970110
Labeler code 65597
Product ID 65597-110_d5485e0f-7c18-4073-91f6-0890243d9bd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate and olmesartan medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Daiichi Sankyo Inc.
Application NDA022100
Marketing category NDA
Marketing start 2007-09-26
Marketing end 2023-05-31
Substance AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength 5 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 0000-00-00
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 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 N022100-001 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 N022100-002 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 N022100-003 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 N022100-004 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26
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 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 65597-110-07 2020-08-14 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7 65597-110-10 2020-08-14 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7 65597-110-11 2020-08-14 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7 65597-110-30 2020-08-14 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7 65597-110-90 2020-08-14 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7 65597-110-07 2020-07-22 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7 65597-110-10 2020-07-22 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7 65597-110-11 2020-07-22 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7 65597-110-30 2020-07-22 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7 65597-110-90 2020-07-22 These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 OLMESARTAN MEDOXOMIL ACTIVE INGREDIENT 6M97XTV3HD AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 AMLODIPINE ACTIVE MOIETY 1J444QC288 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 OLMESARTAN ACTIVE MOIETY 8W1IQP3U10 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 TALC INACTIVE INGREDIENT 7SEV7J4R1U AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 OLMESARTAN MEDOXOMIL ACTIVE INGREDIENT 6M97XTV3HD AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 AMLODIPINE ACTIVE MOIETY 1J444QC288 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 OLMESARTAN ACTIVE MOIETY 8W1IQP3U10 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65597-110-30 65597011030 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-110-30) 2007-09-26 2023-05-31 No No Current