Edarbi

Product NDC: 60631-080
11-digit product format: 606310080
Labeler code: 60631
Product ID: 60631-080_2f63b0e8-977a-4d22-9550-29ad1926a9de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azilsartan kamedoxomil
Dosage form: TABLET
Route: ORAL
Labeler: Azurity Pharmaceuticals, Inc.
Application: NDA200796
Marketing category: NDA
Marketing start: 2013-02-01
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60631-080	60631-080-07	D	Discontinued by firm		2026-08-03

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 · 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.

Application-product, TE code table
Application-product	TE code
N200796-001	AB
N200796-002	AB

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	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: Edarbi
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZILSARTAN KAMEDOXOMIL	80 mg/1

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091646	Internal RxNorm lookup
1091650	Internal RxNorm lookup
1091652	Internal RxNorm lookup
1091654	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
52b27c75-9f5a-4816-bafd-dace9d7d2063	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0450926f-f624-49c2-83be-42807e8fbcd5	Product name	1	20251113
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9c73251d-aa60-4cfe-993e-64d90dc1df32	Product name	1	20201015
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60631-080-07	Edarbi	5 in 1 TRAY	TABLET	5	17
60631-080-07	Edarbi	7 in 1 BLISTER PACK	TABLET	7	17
60631-080-30	Edarbi	30 in 1 BOTTLE	TABLET	30	17
60631-080-77	Edarbi	7 in 1 BOTTLE	TABLET	7	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60631-080-30	EA - Each	60631-080	3456943e-4b4a-4280-a408-ea86d5e92cbc	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Azilsartan kamedoxomil	ACTIVE INGREDIENT	WEC6I2K1FC	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]	5
Azilsartan	ACTIVE MOIETY	F9NUX55P23	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]	5
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]	5
fumaric acid	INACTIVE INGREDIENT	88XHZ13131	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]	5
hydroxypropyl cellulose (type h)	INACTIVE INGREDIENT	RFW2ET671P	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]	5
mannitol	INACTIVE INGREDIENT	3OWL53L36A	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]	5
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60631-080	EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [AZURITY PHARMACEUTICALS, INC.]	17	Current NDC, Legacy NDC, 4 package rows	20240131_52b27c75-9f5a-4816-bafd-dace9d7d2063.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azilsartan Medoxomil	AZILSARTAN KAMEDOXOMIL	Wilshire Pharmaceuticals, Inc.	c09103d8-c094-473d-a303-bbb4f334aa8c	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200796 application number: NDA200796
Edarbi	AZILSARTAN KAMEDOXOMIL	Azurity Pharmaceuticals, Inc.	52b27c75-9f5a-4816-bafd-dace9d7d2063	2024-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200796 application number: NDA200796 ndc (product): 60631-080

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WEC6I2K1FC	AZILSARTAN KAMEDOXOMIL	863031-24-7	AZILSARTAN KAMEDOXOMIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1091646	azilsartan medoxomil 40 MG Oral Tablet	PSN	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091652	azilsartan medoxomil 80 MG Oral Tablet	PSN	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091650	Edarbi 40 MG Oral Tablet	PSN	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091654	Edarbi 80 MG Oral Tablet	PSN	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091650	azilsartan medoxomil 40 MG Oral Tablet [Edarbi]	SBD	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091654	azilsartan medoxomil 80 MG Oral Tablet [Edarbi]	SBD	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091646	azilsartan medoxomil 40 MG Oral Tablet	SCD	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091652	azilsartan medoxomil 80 MG Oral Tablet	SCD	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091646	azilsartan medoxomil 40 MG (equivalent to azilsartan kamedoxomil 42.68 MG) Oral Tablet	SY	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091652	azilsartan medoxomil 80 MG (equivalent to azilsartan kamedoxomil 85.36 MG) Oral Tablet	SY	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091650	Edarbi 40 MG (azilsartan kamedoxomil 42.68 MG) Oral Tablet	SY	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091650	Edarbi 40 MG Oral Tablet	SY	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091654	Edarbi 80 MG (azilsartan kamedoxomil 85.36 MG) Oral Tablet	SY	52b27c75-9f5a-4816-bafd-dace9d7d2063	17
1091654	Edarbi 80 MG Oral Tablet	SY	52b27c75-9f5a-4816-bafd-dace9d7d2063	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60631-080-07	60631008007	5 in 1 TRAY						Historical
60631-080-30	60631008030	30 TABLET in 1 BOTTLE (60631-080-30)	30 tablet	2013-02-01	0000-00-00	No	No	Current
60631-080-77	60631008077	7 TABLET in 1 BOTTLE (60631-080-77)	7 tablet	2017-02-01		No	No	Current