Olmesartan Medoxomil

Product NDC
13668-248
11-digit product format
136680248
Labeler code
13668
Product ID
13668-248_e3a29777-823d-8511-e053-2995a90ab53c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA202375
Marketing category
ANDA
Marketing start
2017-04-24
Marketing end
0000-00-00
Substance
OLMESARTAN MEDOXOMIL
Active strength
5 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13668-248DDiscontinued by firm2026-08-03
excluded packagepackage13668-24813668-248-05DDiscontinued by firm2026-08-03
excluded packagepackage13668-24813668-248-30DDiscontinued by firm2026-08-03
excluded packagepackage13668-24813668-248-90DDiscontinued by firm2026-08-03

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-248-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-248-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-248-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-248-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-248-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-248-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-248-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-248-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-248-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-248-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-248-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-248-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-248-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-248-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-248-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-248-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-248-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-248-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-248-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-248-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-248-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-248-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-248-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-248-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13668-248-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13668-248-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13668-248-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-248-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-248-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-248-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-248-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-248-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-248-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13668-248-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13668-248-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13668-248-30557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202375-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24
A202375-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24
A202375-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202375-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202375-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202375-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-248072bd15b7f6…

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 ZIP2022-06A202375-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202375-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202375-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202375-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202375-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202375-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202375-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202375-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202375-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202375-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202375-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202375-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202375-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202375-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202375-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202375-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202375-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202375-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202375-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202375-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202375-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202375-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202375-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202375-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202375-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202375-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202375-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202375-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202375-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202375-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202375-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A202375-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A202375-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202375-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202375-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202375-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202375-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202375-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202375-003AB1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202375-001AB1a67488948f0b…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-248-30EA - Each13668-248ced24787-e67f-4636-b684-33a23060081712017-05-03
13668-248-90EA - Each13668-248b340370c-a27c-48ad-8b61-0e13953a5d0e12017-05-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-248-0513668024805500 TABLET in 1 BOTTLE (13668-248-05) 500 tablet2017-04-240000-00-00NoNoCurrent
13668-248-301366802483030 TABLET in 1 BOTTLE (13668-248-30) 30 tablet2017-04-240000-00-00NoNoCurrent
13668-248-7413668024874100 TABLET in 1 CARTON (13668-248-74) 100 tablet2017-04-240000-00-00NoNoCurrent
13668-248-901366802489090 TABLET in 1 BOTTLE (13668-248-90) 90 tablet2017-04-240000-00-00NoNoCurrent