FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product NDC
50090-5402
Requested package NDC
50090-5402-0
11-digit product format
500905402
Labeler code
50090
Product ID
50090-5402_aab1c065-4c06-4cfe-bad0-0517c86f9c0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209281
Marketing category
ANDA
Marketing start
2020-09-03
Substance
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength
40; 12.5 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 45.

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
A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2019-02-07
A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2019-02-07
A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2019-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209281-001AB
A209281-002AB
A209281-003AB

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 · 135 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-07d4dbc9d85df4…
2026-11-14 07:37:172026-10A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-07d4dbc9d85df4…
2026-11-14 07:37:172026-10A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-07d4dbc9d85df4…
2026-10-15 13:18:302026-09A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-07c2088c7a36db…
2026-10-15 13:18:302026-09A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-07c2088c7a36db…
2026-10-15 13:18:302026-09A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-07c2088c7a36db…
2026-09-14 22:38:342026-08A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-0784e616aacf4f…
2026-09-14 22:38:342026-08A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-0784e616aacf4f…
2026-09-14 22:38:342026-08A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-0784e616aacf4f…
2026-08-18 06:07:402026-07A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209281-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209281-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209281-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-02-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-11-14 07:37:172026-10A209281-001AB1d4dbc9d85df4…
2026-11-14 07:37:172026-10A209281-002AB1d4dbc9d85df4…
2026-11-14 07:37:172026-10A209281-003AB1d4dbc9d85df4…
2026-10-15 13:18:302026-09A209281-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A209281-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A209281-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A209281-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209281-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209281-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A209281-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209281-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209281-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209281-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209281-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209281-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209281-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209281-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209281-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209281-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209281-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209281-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209281-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209281-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209281-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209281-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209281-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209281-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209281-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209281-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209281-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209281-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209281-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209281-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209281-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209281-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209281-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209281-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209281-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209281-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209281-001AB1d06236e962d9…

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 AND HYDROCHLOROTHIAZIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL40 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M97XTV3HDInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403854Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3df6c955-9c38-4e44-a665-dac2a051bd02Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5402-02023-02-07C16284748780-1f386c64a-2643-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003
50090-5402-02023-01-30C16284748780-1f386c64a-2643-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5402-0OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5402-0EA - Each50090-540201f05874-6cc6-4af6-915b-0625fccb0a8e12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5402OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20241115_3df6c955-9c38-4e44-a665-dac2a051bd02.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 MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAccord Healthcare Inc.d858a6de-dda5-4bcd-a255-5723d01d896f2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209281
application number: ANDA209281
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions3df6c955-9c38-4e44-a665-dac2a051bd022024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209281
application number: ANDA209281
ndc (package): 50090-5402-0
ndc (product): 50090-5402
ndc11 (package): 50090540200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403854olmesartan medoxomil 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN3df6c955-9c38-4e44-a665-dac2a051bd027
403854hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD3df6c955-9c38-4e44-a665-dac2a051bd027
403854HCTZ 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY3df6c955-9c38-4e44-a665-dac2a051bd027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5402-05009054020090 TABLET, FILM COATED in 1 BOTTLE (50090-5402-0) 2020-12-080000-00-00NoNoCurrent