FDA.reportPublic FDA data

olmesartan medoxomil

Product NDC
16729-322
11-digit product format
167290322
Labeler code
16729
Product ID
16729-322_424dbf67-5be3-2810-e063-6294a90a3558
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA207662
Marketing category
ANDA
Marketing start
2017-04-27
Substance
OLMESARTAN MEDOXOMIL
Active strength
40 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

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
A207662-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24
A207662-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24
A207662-003OLMESARTAN 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
A207662-001AB
A207662-002AB
A207662-003AB

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 UTC2026-02A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207662-001OLMESARTAN 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 UTC2026-02A207662-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207662-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207662-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207662-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207662-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207662-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207662-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207662-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207662-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207662-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
olmesartan medoxomil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL40 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
e5dbca00-4e1b-4479-b829-021b11bc021eAvailable 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
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-322-10olmesartan medoxomil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309
16729-322-15olmesartan medoxomil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909
16729-322-16olmesartan medoxomil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5009
16729-322-17olmesartan medoxomil1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10009
16729-322-45olmesartan medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED109
16729-322-46olmesartan medoxomil100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-322-10EA - Each16729-32232652495-1111-4d9f-aace-ad4e998aad4712017-05-03
16729-322-15EA - Each16729-3223370ce2e-2bdf-492e-8f0d-fe51b7bc01dd12017-05-03
16729-322-17EA - Each16729-3222ec01a29-ba82-486e-a07f-385fe953be0912017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-322OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.]8Current NDC, Legacy NDC, 6 package rows20240718_e5dbca00-4e1b-4479-b829-021b11bc021e.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack79e2620d-6554-4e03-8087-59ec2e4dd75b2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILAccord Healthcare Inc.e5dbca00-4e1b-4479-b829-021b11bc021e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
ndc (product): 16729-322
Olmesartan MedoxomilOLMESARTAN MEDOXOMILDirect_Rxe64c3b3b-d5e7-6d46-e053-2a95a90a1b642025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILdirect rxb57e47a5-43e0-d1c5-e053-2a95a90a2b072025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack8a021ffc-8b11-4ddf-81c4-87515971fdee2024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepacka4ceea38-8fff-4317-be04-8dc22222ec702024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILA-S Medication Solutionsb55b6172-d986-4fd9-ba85-a8393c9089492023-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions949e6bad-fcb2-42f2-b9c8-e5620ef5ccd52023-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions7afa79de-d42e-4429-874d-449d47a59fbe2023-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349405olmesartan medoxomil 40 MG Oral TabletPSN8a021ffc-8b11-4ddf-81c4-87515971fdee102
349405olmesartan medoxomil 40 MG Oral TabletSCD8a021ffc-8b11-4ddf-81c4-87515971fdee102
349401olmesartan medoxomil 20 MG Oral TabletPSNe5dbca00-4e1b-4479-b829-021b11bc021e9
349405olmesartan medoxomil 40 MG Oral TabletPSN7afa79de-d42e-4429-874d-449d47a59fbe9
349405olmesartan medoxomil 40 MG Oral TabletPSNe5dbca00-4e1b-4479-b829-021b11bc021e9
349373olmesartan medoxomil 5 MG Oral TabletPSNe5dbca00-4e1b-4479-b829-021b11bc021e9
349401olmesartan medoxomil 20 MG Oral TabletSCDe5dbca00-4e1b-4479-b829-021b11bc021e9
349405olmesartan medoxomil 40 MG Oral TabletSCD7afa79de-d42e-4429-874d-449d47a59fbe9
349405olmesartan medoxomil 40 MG Oral TabletSCDe5dbca00-4e1b-4479-b829-021b11bc021e9
349373olmesartan medoxomil 5 MG Oral TabletSCDe5dbca00-4e1b-4479-b829-021b11bc021e9
349401olmesartan medoxomil 20 MG Oral TabletPSNb57e47a5-43e0-d1c5-e053-2a95a90a2b074
349405olmesartan medoxomil 40 MG Oral TabletPSNb57e47a5-43e0-d1c5-e053-2a95a90a2b074
349401olmesartan medoxomil 20 MG Oral TabletSCDb57e47a5-43e0-d1c5-e053-2a95a90a2b074
349405olmesartan medoxomil 40 MG Oral TabletSCDb57e47a5-43e0-d1c5-e053-2a95a90a2b074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-322-101672903221030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-322-10) 2017-04-270000-00-00NoNoCurrent
16729-322-151672903221590 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-322-15) 2017-04-270000-00-00NoNoCurrent
16729-322-1616729032216500 in 1 BOTTLE, PLASTICHistorical
16729-322-17167290322171000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-322-17) 2017-04-270000-00-00NoNoCurrent
16729-322-451672903224510 in 1 BLISTER PACKHistorical
16729-322-4616729032246100 in 1 BOX, UNIT-DOSEHistorical