FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product NDC
13668-252
Requested package NDC
13668-252-01
11-digit product format
136680252
Labeler code
13668
Product ID
13668-252_0f14431f-59f1-4bac-a78c-55cd0147c727
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA206515
Marketing category
ANDA
Marketing start
2017-04-24
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
13 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
2023-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13668-25213668-252-01DDiscontinued by firm2026-10-20

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORAL2017-05-03
A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORAL2017-05-03
A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORAL2017-05-03

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-05-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-05-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-05-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2017-05-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2017-05-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORAL2017-05-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-05-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-05-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-05-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-05-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-05-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-05-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-0387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-0387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-05-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-035aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-035aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-05-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-038869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-038869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206515-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2017-05-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206515-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2017-05-03c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206515-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-05-03c0c555d07b60…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206515-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206515-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206515-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206515-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206515-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206515-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206515-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206515-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206515-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206515-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206515-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206515-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206515-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206515-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206515-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206515-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206515-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206515-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206515-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206515-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206515-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206515-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206515-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206515-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206515-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206515-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206515-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206515-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206515-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206515-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206515-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206515-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206515-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206515-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206515-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206515-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206515-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206515-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206515-003AB1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206515-001AB1a67488948f0b…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-252-30EA - Each13668-25287ae5c7d-e9ed-44a7-b55a-237df28778b612017-05-03
13668-252-90EA - Each13668-252de977fe4-2c4b-4757-be2b-d999aa84415312017-05-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-252-01136680252011000 TABLET in 1 BOTTLE (13668-252-01) 1000 tablet2017-04-240000-00-00NoNoCurrent