FDA.reportPublic FDA data

Olmesartan medoxomil

Product NDC
71335-3162
Requested package NDC
71335-3162-1
11-digit product format
713353162
Labeler code
71335
Product ID
71335-3162_1b9ea11a-c9e8-448d-b999-ac81a1b11a5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217399
Marketing category
ANDA
Marketing start
2023-01-18
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
2027-12-31
Current FDA listing
Yes

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
A217399-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-18
A217399-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-18
A217399-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217399-001AB
A217399-002AB
A217399-003AB

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 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-18c2088c7a36db…
2026-09-14 22:38:342026-08A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-1884e616aacf4f…
2026-08-18 06:07:402026-07A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A217399-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2023-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A217399-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2023-01-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217399-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2023-01-1879d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A217399-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A217399-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A217399-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A217399-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A217399-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A217399-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A217399-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217399-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217399-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217399-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217399-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217399-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217399-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217399-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217399-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217399-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217399-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217399-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217399-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217399-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217399-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217399-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217399-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217399-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217399-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217399-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217399-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217399-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217399-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217399-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217399-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217399-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217399-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217399-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217399-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217399-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217399-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217399-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217399-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217399-001AB179d66fd596c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Olmesartan medoxomil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL5 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6b8585a2-22e0-4a4f-a1c3-24bcdec01834Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack6b8585a2-22e0-4a4f-a1c3-24bcdec018342026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217399
application number: ANDA217399
ndc (package): 71335-3162-1
ndc (product): 71335-3162
ndc11 (package): 71335316201
Olmesartan medoxomilOLMESARTAN MEDOXOMILNovadoz Pharmaceuticals LLC4238a064-1bfd-4ce3-b9d9-12c96eee8af02023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217399
application number: ANDA217399

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3162-17133531620190 TABLET, FILM COATED in 1 BOTTLE (71335-3162-1) 2026-07-27NoNoCurrent