Home NDC 60631-412 Edarbyclor
Product NDC 60631-412
11-digit product format 606310412
Labeler code 60631
Product ID 60631-412_26b92714-c5ea-943d-e063-6394a90a8341
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azilsartan kamedoxomil and chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Application NDA202331
Marketing category NDA
Marketing start 2013-02-01
Substance AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Active strength 40; 12.5 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE], Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 3 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 2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 60631-412 60631-412-07 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 60631-412 60631-412-07 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 60631-412 60631-412-07 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 N202331-001 EDARBYCLOR AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 N202331-002 EDARBYCLOR AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202331-001 9066936 2028-03-26 Drug product 2015-07-30 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 N202331-001 9387249 2031-07-01 U-3 2019-08-15 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 N202331-002 9387249 2031-07-01 U-3 2019-08-15
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 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB RLD 2011-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB RLD, RS 2011-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202331-001 EDARBYCLOR EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL RLD 2011-12-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202331-002 EDARBYCLOR EQ 40MG MEDOXOMIL;25MG TABLET / ORAL RLD, RS 2011-12-20 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 10 · 400 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 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-001 9387249 2031-07-01 U-3 2019-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202331-002 9387249 2031-07-01 U-3 2019-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 7572920 2025-01-07 U-3 Drug product 2012-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 7157584 2025-05-22 Drug substance 2012-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-001 9387249 2031-07-01 U-3 2019-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 7572920 2025-01-07 U-3 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 7157584 2025-05-22 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202331-002 9387249 2031-07-01 U-3 2019-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202331-001 7572920 2025-01-07 U-3 Drug product 2012-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-001 7157584 2025-05-22 Drug substance 2012-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-001 9387249 2031-07-01 U-3 2019-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 7572920 2025-01-07 U-3 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 7157584 2025-05-22 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202331-002 9387249 2031-07-01 U-3 2019-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 7572920 2025-01-07 U-3 Drug product 2012-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 7157584 2025-05-22 Drug substance 2012-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-001 9387249 2031-07-01 U-3 2019-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 7572920 2025-01-07 U-3 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 7157584 2025-05-22 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 9066936 2028-03-26 Drug product 2015-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 9169238 2030-02-04 Drug product 2015-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202331-002 9387249 2031-07-01 U-3 2019-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 7572920 2025-01-07 U-3 Drug product 2012-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 7157584 2025-05-22 Drug substance 2012-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 9066936 2028-03-26 Drug product 2015-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202331-001 9169238 2030-02-04 Drug product 2015-11-19 b8a1b40f171c…
Additional Listing Data#
Finished product Yes
Brand name base Edarbyclor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZILSARTAN KAMEDOXOMIL 40 mg/1 CHLORTHALIDONE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q0MQD1073Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1235144 Internal RxNorm lookup 1235150 Internal RxNorm lookup 1235151 Internal RxNorm lookup 1235157 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 60631-412-30 Edarbyclor 30 in 1 BOTTLE TABLET 30 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60631-412 EDARBYCLOR (AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE) TABLET [AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)] 18 Current NDC, Legacy NDC, 1 package rows 20241115_e60f795b-fce3-4361-aa03-f143451689d1.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Edarbyclor AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) e60f795b-fce3-4361-aa03-f143451689d1 2022-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202331 application number: NDA202331 ndc (product): 60631-412
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60631-412-30 60631041230 30 TABLET in 1 BOTTLE (60631-412-30) 30 tablet 2013-02-01 0000-00-00 No No Current