Olmesartan Medoxomil and Hydrochlorothiazide

Product NDC: 63629-7570
Requested package NDC: 63629-7570-2
11-digit product format: 636297570
Labeler code: 63629
Product ID: 63629-7570_752c5f7e-2fd6-49c8-95d9-1e5fe93766b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil and Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA205391
Marketing category: ANDA
Marketing start: 2017-04-24
Marketing end: 0000-00-00
Substance: OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength: 20 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: 2021-12-31
Current FDA listing: Historical FDA.report record

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	63629-7570	63629-7570-2	D	Discontinued by firm		2026-10-05

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 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24
A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24
A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET / ORAL	AB	2017-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205391-001	AB
A205391-002	AB
A205391-003	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 · 129 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	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A205391-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205391-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205391-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205391-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205391-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205391-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205391-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205391-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205391-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205391-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205391-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205391-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205391-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205391-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205391-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205391-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205391-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205391-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205391-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205391-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205391-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205391-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205391-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205391-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205391-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205391-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205391-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205391-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205391-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205391-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205391-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205391-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205391-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205391-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205391-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205391-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205391-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205391-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205391-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205391-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-7570-1	2020-10-16	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003
63629-7570-2	2020-10-16	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003
63629-7570-3	2020-10-16	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003
63629-7570-1	2020-01-31	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003
63629-7570-2	2020-01-31	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003
63629-7570-3	2020-01-31	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003

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 · 5 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	Bryant Ranch Prepack	0360db3a-17cf-4d24-97ba-e0a6fcc94351	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	744c1785-42b2-46a5-b0f4-2887a9ec2051	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	fe49d96e-5874-4b11-9323-b4a92e9c25dc	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b78ad43f-f132-4f03-8c85-2cf9b3ab555b	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ad1b2af1-3713-4776-bf48-d776073d9781	2024-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391

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	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7570-2	63629757002	60 TABLET, FILM COATED in 1 BOTTLE (63629-7570-2)	2018-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olmesartan Medoxomil and Hydrochlorothiazide	Bryant Ranch Prepack	2020-10-16	Human Prescription Drug Label	5