Home NDC 52536-008 Azilsartan Medoxomil
Product NDC 52536-008
11-digit product format 525360008
Labeler code 52536
Product ID 52536-008_c09103d8-c094-473d-a303-bbb4f334aa8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azilsartan kamedoxomil
Dosage form TABLET
Route ORAL
Labeler Wilshire Pharmaceuticals, Inc.
Application NDA200796
Marketing category NDA
Marketing start 2026-04-27
Substance AZILSARTAN KAMEDOXOMIL
Active strength 80 mg/1
Pharmacologic classes Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N200796-001 EDARBI AZILSARTAN KAMEDOXOMIL EQ 40MG MEDOXOMIL TABLET / ORAL AB RLD 2011-02-25 N200796-002 EDARBI AZILSARTAN KAMEDOXOMIL EQ 80MG MEDOXOMIL TABLET / ORAL AB RLD, RS 2011-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N200796-001 9066936 2028-03-26 Drug product 2015-07-30 N200796-002 9066936 2028-03-26 Drug product 2015-07-30
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 3 · 82 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 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N200796-001 EDARBI EQ 40MG MEDOXOMIL TABLET / ORAL RLD 2011-02-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N200796-002 EDARBI EQ 80MG MEDOXOMIL TABLET / ORAL RLD, RS 2011-02-25 782e0a99824c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N200796-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N200796-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 238 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-001 7572920 2025-01-07 U-3 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-001 7157584 2025-05-22 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-002 7572920 2025-01-07 U-3 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-002 7157584 2025-05-22 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200796-001 7572920 2025-01-07 U-3 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200796-001 7157584 2025-05-22 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200796-002 7572920 2025-01-07 U-3 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200796-002 7157584 2025-05-22 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-001 7572920 2025-01-07 U-3 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-001 7157584 2025-05-22 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-002 7572920 2025-01-07 U-3 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-002 7157584 2025-05-22 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-001 7572920 2025-01-07 U-3 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-001 7157584 2025-05-22 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-002 7572920 2025-01-07 U-3 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-002 7157584 2025-05-22 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-001 7572920 2025-01-07 U-3 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-001 7157584 2025-05-22 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-002 7572920 2025-01-07 U-3 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-002 7157584 2025-05-22 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-001 7572920 2025-01-07 U-3 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-001 7157584 2025-05-22 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-001 9066936 2028-03-26 Drug product 2015-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-002 7572920 2025-01-07 U-3 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-002 7157584 2025-05-22 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200796-002 9066936 2028-03-26 Drug product 2015-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-001 7572920 2025-01-07 U-3 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200796-001 7157584 2025-05-22 Drug substance 5bbf6a4d5a75…
Additional Listing Data#
Finished product Yes
Brand name base Azilsartan Medoxomil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZILSARTAN KAMEDOXOMIL 80 mg/1
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091646 Internal RxNorm lookup 1091652 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52536-008-03 Azilsartan Medoxomil 30 in 1 BOTTLE TABLET 30 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 Units Marketing start Sample Exclude flag Status 52536-008-03 52536000803 30 TABLET in 1 BOTTLE (52536-008-03) 30 tablet 2026-04-27 No No Current