olmesartan medoxomil

Product NDC
68382-643
11-digit product format
683820643
Labeler code
68382
Product ID
68382-643_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
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68382-643DDiscontinued by firm2026-10-15
excluded packagepackage68382-64368382-643-01DDiscontinued by firm2026-10-15
excluded packagepackage68382-64368382-643-05DDiscontinued by firm2026-10-15
excluded packagepackage68382-64368382-643-06DDiscontinued by firm2026-10-15
excluded packagepackage68382-64368382-643-10DDiscontinued by firm2026-10-15
excluded packagepackage68382-64368382-643-16DDiscontinued by firm2026-10-15
excluded packagepackage68382-64368382-643-77DDiscontinued by firm2026-10-15

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 packagepackage68382-643-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-643-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-643-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-643-77d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-643-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-643-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-643-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-643-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-643-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-643-77f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-643-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-643-16f5e01cc5f278…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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11A205192-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205192-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A205192-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A205192-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205192-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A205192-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A205192-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205192-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A205192-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A205192-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205192-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205192-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205192-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205192-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A205192-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A205192-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205192-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A205192-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A205192-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205192-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205192-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205192-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205192-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205192-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205192-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205192-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205192-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205192-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205192-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205192-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205192-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205192-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A205192-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A205192-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205192-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A205192-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A205192-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205192-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205192-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205192-003AB13a93d1ddd44b…

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
68382-643-06EA - Each68382-6435e6bc851-2a94-47c5-87b6-28e2da76260112017-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-643-0168382064301100 TABLET, FILM COATED in 1 BOTTLE (68382-643-01) 2017-04-240000-00-00NoNoCurrent
68382-643-0568382064305500 TABLET, FILM COATED in 1 BOTTLE (68382-643-05) 2017-04-240000-00-00NoNoCurrent
68382-643-066838206430630 TABLET, FILM COATED in 1 BOTTLE (68382-643-06) 2017-04-240000-00-00NoNoCurrent
68382-643-10683820643101000 TABLET, FILM COATED in 1 BOTTLE (68382-643-10) 2017-04-240000-00-00NoNoCurrent
68382-643-166838206431690 TABLET, FILM COATED in 1 BOTTLE (68382-643-16) 2017-04-240000-00-00NoNoCurrent
68382-643-776838206437710 BLISTER PACK in 1 CARTON (68382-643-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-643-30) 10 blister pack2017-04-240000-00-00NoNoCurrent