Home NDC 65597-104-06 Benicar
Product NDC 65597-104
Requested package NDC 65597-104-06
11-digit product format 655970104
Labeler code 65597
Product ID 65597-104_9a1acd82-0655-4e72-9177-12ddf31c4b1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Daiichi Sankyo, Inc.
Application NDA021286
Marketing category NDA
Marketing start 2002-04-25
Marketing end 2024-03-31
Substance OLMESARTAN MEDOXOMIL
Active strength 40 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
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 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 N021286-001 BENICAR OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB RLD 2002-04-25 N021286-003 BENICAR OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB RLD 2002-04-25 N021286-004 BENICAR OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB RLD, RS 2002-04-25
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 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021286-003 BENICAR 20MG TABLET / ORAL AB RLD 2002-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021286-004 BENICAR 40MG TABLET / ORAL AB RLD, RS 2002-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021286-001 BENICAR 5MG TABLET / ORAL AB RLD 2002-04-25 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OLMESARTAN MEDOXOMIL ACTIVE INGREDIENT 6M97XTV3HD BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 OLMESARTAN ACTIVE MOIETY 8W1IQP3U10 BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 15 OLMESARTAN MEDOXOMIL ACTIVE INGREDIENT 6M97XTV3HD BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] 7 OLMESARTAN ACTIVE MOIETY 8W1IQP3U10 BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] 7 olmesartan medoxomil ACTIVE INGREDIENT 6M97XTV3HD BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 olmesartan ACTIVE MOIETY 8W1IQP3U10 BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 hypromellose INACTIVE INGREDIENT BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 low-substituted hydroxypropyl cellulose INACTIVE INGREDIENT BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 microcrystalline cellulose INACTIVE INGREDIENT BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 talc INACTIVE INGREDIENT 7SEV7J4R1U BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 yellow iron oxide INACTIVE INGREDIENT EX438O2MRT BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO] 2 OLMESARTAN MEDOXOMIL ACTIVE INGREDIENT 6M97XTV3HD BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 OLMESARTAN ACTIVE MOIETY 8W1IQP3U10 BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1
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 65597-104-06 65597010406 180 TABLET, FILM COATED in 1 BOX (65597-104-06) 2002-04-25 2024-03-31 No No Current