Olmesartan Medoxomil and Hydrochlorothiazide

Product NDC: 60290-102
11-digit product format: 602900102
Labeler code: 60290
Product ID: 60290-102_5cace214-8690-0a8c-e063-6394a90a4c47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Umedica Laboratories USA Inc.
Application: ANDA208847
Marketing category: ANDA
Marketing start: 2026-02-15
Substance: OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength: 20; 12.5 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 43.

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	Approval date
A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17
A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET / ORAL	AB	2019-09-17
A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208847-001	AB
A208847-002	AB
A208847-003	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208847-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208847-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208847-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-09-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208847-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208847-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208847-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208847-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208847-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208847-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208847-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208847-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208847-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208847-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208847-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208847-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208847-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208847-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208847-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208847-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208847-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208847-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208847-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208847-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208847-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208847-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208847-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208847-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208847-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208847-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208847-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208847-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208847-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208847-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208847-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208847-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208847-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208847-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208847-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208847-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208847-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208847-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208847-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208847-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Olmesartan Medoxomil and Hydrochlorothiazide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLMESARTAN MEDOXOMIL	20 mg/1
HYDROCHLOROTHIAZIDE	12.5 mg/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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Umedica Laboratories USA Inc.	55d6aee1-01ca-4791-8404-386664b4ab07	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208847 application number: ANDA208847 ndc (product): 60290-102
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	77e71a2e-8370-4f7a-a5e4-93d86bd37dad	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208847 application number: ANDA208847
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Lifestar Pharma LLC	9771066e-c05d-6a93-e053-2995a90a7e87	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208847 application number: ANDA208847
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ba452478-f40c-446e-b61d-388379a55efd	2023-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208847 application number: ANDA208847

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M97XTV3HD	OLMESARTAN MEDOXOMIL	144689-63-4	OLMESARTAN MEDOXOMIL
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60290-102-01	60290010201	30 TABLET in 1 BOTTLE (60290-102-01)	30 tablet	2026-02-15	No	No	Current
60290-102-02	60290010202	90 TABLET in 1 BOTTLE (60290-102-02)	90 tablet	2026-02-15	No	No	Current
60290-102-03	60290010203	500 TABLET in 1 BOTTLE (60290-102-03)	500 tablet	2026-02-15	No	No	Current
60290-102-04	60290010204	1000 TABLET in 1 BOTTLE (60290-102-04)	1000 tablet	2026-02-15	No	No	Current
60290-102-05	60290010205	100 TABLET in 1 BLISTER PACK (60290-102-05)	100 tablet	2026-02-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olmesartan Medoxomil and Hydrochlorothiazide	Umedica Laboratories USA Inc. \| UMEDICA LABORATORIES PRIVATE LIMITED	2026-09-30	HUMAN PRESCRIPTION DRUG LABEL	12