Home NDC 0713-0862 Benicar
Product NDC 0713-0862
11-digit product format 007130862
Labeler code 0713
Product ID 0713-0862_00494313-514a-b3b5-e063-6294a90a5ad5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cosette Pharmaceuticals, Inc.
Application NDA021286
Marketing category NDA
Marketing start 2022-09-01
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 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Benicar
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M97XTV3HD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349373 Internal RxNorm lookup 349401 Internal RxNorm lookup 349405 Internal RxNorm lookup 352199 Internal RxNorm lookup 352200 Internal RxNorm lookup 352201 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0862-30 Benicar 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0862 BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20230713_5b6f8a18-8f8a-4521-81c3-3a39c73c6646.zip
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 0713-0862-30 00713086230 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0862-30) 2022-09-01 0000-00-00 No No Current