Olmesartan Medoxomil

Product NDC
62332-133
11-digit product format
623320133
Labeler code
62332
Product ID
62332-133_95e8d157-e834-4d1d-9520-8ee05f8ca69b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA203012
Marketing category
ANDA
Marketing start
2017-04-24
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
A203012-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24
A203012-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24
A203012-003OLMESARTAN 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
A203012-001AB
A203012-002AB
A203012-003AB

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 UTC2026-02A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203012-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203012-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203012-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203012-001OLMESARTAN 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 UTC2026-02A203012-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203012-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203012-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203012-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203012-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203012-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203012-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203012-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203012-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203012-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203012-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203012-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203012-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203012-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203012-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203012-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203012-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203012-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203012-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203012-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203012-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203012-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203012-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203012-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203012-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203012-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203012-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203012-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203012-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203012-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203012-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203012-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203012-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203012-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203012-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203012-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203012-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203012-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203012-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203012-001AB18072bd15b7f6…

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
cf4f62f9-5a00-4313-b703-ec0ac6380b5eAvailable 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
62332-133-10Olmesartan Medoxomil100 in 1 CARTONTABLET, FILM COATED10010
62332-133-30Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED3010
62332-133-90Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED9010
62332-133-91Olmesartan Medoxomil1000 in 1 BOTTLETABLET, FILM COATED100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-133-30EA - Each62332-133eceffd7c-7244-47b2-b15b-bc78cee8cb4e12017-05-04
62332-133-90EA - Each62332-133d9157f1d-e1db-49e7-b004-1e5fc705770312017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-133OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 4 package rows20230928_cf4f62f9-5a00-4313-b703-ec0ac6380b5e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan MedoxomilOLMESARTAN MEDOXOMILAlembic Pharmaceuticals Inc.cf4f62f9-5a00-4313-b703-ec0ac6380b5e2023-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203012
application number: ANDA203012
ndc (product): 62332-133
Olmesartan MedoxomilOLMESARTAN MEDOXOMILAlembic Pharmaceuticals Limitedac08ea7d-f529-42ca-850a-a0ecce7dc8302023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203012
application number: ANDA203012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNcf4f62f9-5a00-4313-b703-ec0ac6380b5e10
349405olmesartan medoxomil 40 MG Oral TabletPSNcf4f62f9-5a00-4313-b703-ec0ac6380b5e10
349373olmesartan medoxomil 5 MG Oral TabletPSNcf4f62f9-5a00-4313-b703-ec0ac6380b5e10
349401olmesartan medoxomil 20 MG Oral TabletSCDcf4f62f9-5a00-4313-b703-ec0ac6380b5e10
349405olmesartan medoxomil 40 MG Oral TabletSCDcf4f62f9-5a00-4313-b703-ec0ac6380b5e10
349373olmesartan medoxomil 5 MG Oral TabletSCDcf4f62f9-5a00-4313-b703-ec0ac6380b5e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-133-1062332013310100 TABLET, FILM COATED in 1 CARTON (62332-133-10) 2017-04-240000-00-00NoNoCurrent
62332-133-306233201333030 TABLET, FILM COATED in 1 BOTTLE (62332-133-30) 2017-04-240000-00-00NoNoCurrent
62332-133-906233201339090 TABLET, FILM COATED in 1 BOTTLE (62332-133-90) 2017-04-240000-00-00NoNoCurrent
62332-133-91623320133911000 TABLET, FILM COATED in 1 BOTTLE (62332-133-91) 2017-04-240000-00-00NoNoCurrent