olmesartan medoxomil

Product NDC
68382-644
11-digit product format
683820644
Labeler code
68382
Product ID
68382-644_0fb52f36-690a-4321-a374-345bfacf74b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA205192
Marketing category
ANDA
Marketing start
2017-04-24
Marketing end
0000-00-00
Substance
OLMESARTAN MEDOXOMIL
Active strength
20 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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68382-644DDiscontinued by firm2026-10-16
excluded packagepackage68382-64468382-644-01DDiscontinued by firm2026-10-16
excluded packagepackage68382-64468382-644-05DDiscontinued by firm2026-10-16
excluded packagepackage68382-64468382-644-06DDiscontinued by firm2026-10-16
excluded packagepackage68382-64468382-644-10DDiscontinued by firm2026-10-16
excluded packagepackage68382-64468382-644-16DDiscontinued by firm2026-10-16
excluded packagepackage68382-64468382-644-77DDiscontinued by firm2026-10-16

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 · 14 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 packagepackage68382-644-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-644-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-644-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-644-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-644-77d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-644-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-644-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-644-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-644-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-644-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-644-77f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-644-10f5e01cc5f278…a2eaf40c39c3…

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
A205192-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24
A205192-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24
A205192-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205192-001AB
A205192-002AB
A205192-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24c2088c7a36db…
2026-10-15 13:18:302026-09A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24c2088c7a36db…
2026-10-15 13:18:302026-09A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24c2088c7a36db…
2026-09-14 22:38:342026-08A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2484e616aacf4f…
2026-09-14 22:38:342026-08A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2484e616aacf4f…
2026-09-14 22:38:342026-08A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2484e616aacf4f…
2026-08-18 06:07:402026-07A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A205192-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A205192-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205192-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2479d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205192-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205192-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205192-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205192-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205192-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205192-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205192-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205192-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205192-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205192-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205192-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205192-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205192-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205192-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205192-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205192-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205192-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205192-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205192-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205192-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205192-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205192-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205192-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205192-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205192-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205192-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205192-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205192-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205192-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205192-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205192-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205192-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205192-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A205192-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A205192-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205192-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A205192-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A205192-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205192-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A205192-002AB1c0c555d07b60…

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
68382-644-06EA - Each68382-644a5172e95-70f6-4381-bc22-6b75daeeb00112017-05-04
68382-644-16EA - Each68382-644202aa58c-144f-4927-b834-222089af6e3612017-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-644-0168382064401100 TABLET, FILM COATED in 1 BOTTLE (68382-644-01) 2017-04-240000-00-00NoNoCurrent
68382-644-0568382064405500 TABLET, FILM COATED in 1 BOTTLE (68382-644-05) 2017-04-240000-00-00NoNoCurrent
68382-644-066838206440630 TABLET, FILM COATED in 1 BOTTLE (68382-644-06) 2017-04-240000-00-00NoNoCurrent
68382-644-10683820644101000 TABLET, FILM COATED in 1 BOTTLE (68382-644-10) 2017-04-240000-00-00NoNoCurrent
68382-644-166838206441690 TABLET, FILM COATED in 1 BOTTLE (68382-644-16) 2017-04-240000-00-00NoNoCurrent
68382-644-776838206447710 BLISTER PACK in 1 CARTON (68382-644-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-644-30) 10 blister pack2017-04-240000-00-00NoNoCurrent