Azilsartan medoxomil

Product NDC: 70748-236
11-digit product format: 707480236
Labeler code: 70748
Product ID: 70748-236_f05aba4d-376f-460f-9264-ecf267e04dcd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azilsartan medoxomil
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA214489
Marketing category: ANDA
Marketing start: 2026-05-14
Substance: AZILSARTAN KAMEDOXOMIL
Active strength: 40 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
A214489-001	AZILSARTAN MEDOXOMIL	AZILSARTAN KAMEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	AB		2022-07-20
A214489-002	AZILSARTAN MEDOXOMIL	AZILSARTAN KAMEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	AB		2022-07-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214489-001	AB
A214489-002	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A214489-001	PC	2026-12-12
A214489-002	PC	2026-12-12

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 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214489-001	AZILSARTAN MEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214489-002	AZILSARTAN MEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET / ORAL	2022-07-20	`a67488948f0b…`

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	A214489-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214489-002	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214489-001	PC	2026-12-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214489-002	PC	2026-12-12	`a50c72e98297…`

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	40 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b1c8de43-3b26-408f-8c7e-6c7d76348199	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
9c73251d-aa60-4cfe-993e-64d90dc1df32	Product name	1	20201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70748-236-06	Azilsartan medoxomil	30 in 1 BOTTLE	TABLET	30		7

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
Azilsartan medoxomil	AZILSARTAN MEDOXOMIL	Lupin Pharmaceuticals, Inc.	b1c8de43-3b26-408f-8c7e-6c7d76348199	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214489 application number: ANDA214489 ndc (product): 70748-236

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WEC6I2K1FC	AZILSARTAN KAMEDOXOMIL	863031-24-7	AZILSARTAN KAMEDOXOMIL
LL0G25K7I2	AZILSARTAN MEDOXOMIL	863031-21-4	Azilsartan medoxomil

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1091646	azilsartan medoxomil 40 MG Oral Tablet	PSN	b1c8de43-3b26-408f-8c7e-6c7d76348199	7
1091652	azilsartan medoxomil 80 MG Oral Tablet	PSN	b1c8de43-3b26-408f-8c7e-6c7d76348199	7
1091646	azilsartan medoxomil 40 MG Oral Tablet	SCD	b1c8de43-3b26-408f-8c7e-6c7d76348199	7
1091652	azilsartan medoxomil 80 MG Oral Tablet	SCD	b1c8de43-3b26-408f-8c7e-6c7d76348199	7
1091646	azilsartan medoxomil 40 MG (equivalent to azilsartan kamedoxomil 42.68 MG) Oral Tablet	SY	b1c8de43-3b26-408f-8c7e-6c7d76348199	7
1091652	azilsartan medoxomil 80 MG (equivalent to azilsartan kamedoxomil 85.36 MG) Oral Tablet	SY	b1c8de43-3b26-408f-8c7e-6c7d76348199	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70748-236-06	70748023606	30 TABLET in 1 BOTTLE (70748-236-06)	30 tablet	2026-05-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azilsartan medoxomil	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	7