FDA.reportPublic FDA data

Olmesartan Medoxomil

Product NDC
65862-742
11-digit product format
658620742
Labeler code
65862
Product ID
65862-742_6135c8a8-0232-4aa1-be56-8c29a444d96f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204798
Marketing category
ANDA
Marketing start
2017-04-24
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
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-742UNFINISHEDActive or certified unfinished drug listing2026-08-03
unfinished packagepackage65862-74265862-742-49UNFINISHEDActive or certified unfinished drug listing2026-08-03

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 · 42 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 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-742-49a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-742-491d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-742-49390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-742-49e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-742-49bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-742-49f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-742-49f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-742-4968b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-742-4905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-742-4948b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-742-4927f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-742-498d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-742-49d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-742-4950b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-742-49906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-742-496db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-742-498fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-742-494184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-742-494bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-742-49263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage65862-742-495b2001dcd8f5…54b53d4dc9e4…

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
A204798-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24
A204798-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24
A204798-003OLMESARTAN 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
A204798-001AB
A204798-002AB
A204798-003AB

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 · 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 UTC2026-02A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204798-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204798-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204798-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204798-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204798-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204798-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204798-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204798-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204798-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204798-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204798-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204798-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204798-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204798-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204798-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204798-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204798-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204798-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204798-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204798-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204798-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204798-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204798-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204798-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204798-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204798-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204798-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204798-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204798-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204798-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204798-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204798-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204798-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204798-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204798-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204798-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204798-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204798-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204798-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204798-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204798-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204798-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204798-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Olmesartan Medoxomil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M97XTV3HDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349373Internal RxNorm lookup
349401Internal RxNorm lookup
349405Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c94d403-809b-43b9-834f-3ecd330d2dd9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-742-01Olmesartan Medoxomil100 in 1 BOTTLETABLET, FILM COATED1009
65862-742-05Olmesartan Medoxomil500 in 1 BOTTLETABLET, FILM COATED5009
65862-742-10Olmesartan Medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED109
65862-742-30Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED309
65862-742-78Olmesartan Medoxomil10 in 1 CARTONTABLET, FILM COATED109
65862-742-90Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED909
65862-742-99Olmesartan Medoxomil1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-742-30EA - Each65862-7424d3dae50-5c69-4bf3-a29b-bc216072f37a12017-05-04
65862-742-90EA - Each65862-74223550f03-ff4d-4cf9-ad4b-4175663a333312017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-742OLMESARTAN MEDOXOMIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 7 package rows20250108_8c94d403-809b-43b9-834f-3ecd330d2dd9.zip

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan MedoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack0a49d951-dd1b-413b-99e5-d3119267c46c2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204798
application number: ANDA204798
Olmesartan MedoxomilOLMESARTAN MEDOXOMILAurobindo Pharma Limited8c94d403-809b-43b9-834f-3ecd330d2dd92025-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204798
application number: ANDA204798
ndc (product): 65862-742
Olmesartan MedoxomilOLMESARTAN MEDOXOMILDirect_Rx16754802-d5a4-0350-e063-6394a90aa9672024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204798
application number: ANDA204798
Olmesartan MedoxomilOLMESARTAN MEDOXOMILQUALLENT PHARMACEUTICALS HEALTH LLC98f930d5-f7c2-4870-92b4-0ad37ce457972024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204798
application number: ANDA204798
Olmesartan MedoxomilOLMESARTAN MEDOXOMILDirect_Rx16752f60-655a-f727-e063-6394a90a96b62024-04-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204798
application number: ANDA204798
Olmesartan MedoxomilOLMESARTAN MEDOXOMILProficient Rx LPe210f962-9b91-46c6-af8f-9f9a9ae842452019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204798
application number: ANDA204798

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN8c94d403-809b-43b9-834f-3ecd330d2dd99
349405olmesartan medoxomil 40 MG Oral TabletPSN8c94d403-809b-43b9-834f-3ecd330d2dd99
349373olmesartan medoxomil 5 MG Oral TabletPSN8c94d403-809b-43b9-834f-3ecd330d2dd99
349401olmesartan medoxomil 20 MG Oral TabletSCD8c94d403-809b-43b9-834f-3ecd330d2dd99
349405olmesartan medoxomil 40 MG Oral TabletSCD8c94d403-809b-43b9-834f-3ecd330d2dd99
349373olmesartan medoxomil 5 MG Oral TabletSCD8c94d403-809b-43b9-834f-3ecd330d2dd99
349401olmesartan medoxomil 20 MG Oral TabletPSNe210f962-9b91-46c6-af8f-9f9a9ae842452
349405olmesartan medoxomil 40 MG Oral TabletPSNe210f962-9b91-46c6-af8f-9f9a9ae842452
349401olmesartan medoxomil 20 MG Oral TabletSCDe210f962-9b91-46c6-af8f-9f9a9ae842452
349405olmesartan medoxomil 40 MG Oral TabletSCDe210f962-9b91-46c6-af8f-9f9a9ae842452
349401olmesartan medoxomil 20 MG Oral TabletPSN16752f60-655a-f727-e063-6394a90a96b61
349401olmesartan medoxomil 20 MG Oral TabletSCD16752f60-655a-f727-e063-6394a90a96b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-742-0165862074201100 TABLET, FILM COATED in 1 BOTTLE (65862-742-01) 2017-04-240000-00-00NoNoCurrent
65862-742-0565862074205500 TABLET, FILM COATED in 1 BOTTLE (65862-742-05) 2017-04-240000-00-00NoNoCurrent
65862-742-106586207421010 in 1 BLISTER PACKHistorical
65862-742-306586207423030 TABLET, FILM COATED in 1 BOTTLE (65862-742-30) 2017-04-240000-00-00NoNoCurrent
65862-742-49658620742494000 TABLET, FILM COATED in 1 BAG (65862-742-49)24-APR-17Current
65862-742-786586207427810 BLISTER PACK in 1 CARTON (65862-742-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-742-10) 10 blister pack2017-04-240000-00-00NoNoCurrent
65862-742-906586207429090 TABLET, FILM COATED in 1 BOTTLE (65862-742-90) 2017-04-240000-00-00NoNoCurrent
65862-742-99658620742991000 TABLET, FILM COATED in 1 BOTTLE (65862-742-99) 2017-04-240000-00-00NoNoCurrent