FDA.reportPublic FDA data

Olmesartan Medoxomil and Hydrochlorothiazide

Product NDC
70756-813
11-digit product format
707560813
Labeler code
70756
Product ID
70756-813_45806c19-480f-987e-e063-6394a90aa8fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA208847
Marketing category
ANDA
Marketing start
2020-10-01
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 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
A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2019-09-17
A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2019-09-17
A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2019-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208847-001AB
A208847-002AB
A208847-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17c2088c7a36db…
2026-10-15 13:18:302026-09A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17c2088c7a36db…
2026-10-15 13:18:302026-09A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17c2088c7a36db…
2026-09-14 22:38:342026-08A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-1784e616aacf4f…
2026-08-18 06:07:402026-07A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208847-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2019-09-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208847-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208847-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2019-09-1779d66fd596c7…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208847-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208847-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208847-003AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208847-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208847-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208847-003AB1a50c72e98297…

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
0J48LPH2THInternal UNII lookup
6M97XTV3HDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403853Internal RxNorm lookup
403854Internal RxNorm lookup
403855Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9771066e-c05d-6a93-e053-2995a90a7e87Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-813-12Olmesartan Medoxomil and Hydrochlorothiazide1000 in 1 BOTTLETABLET100019
70756-813-30Olmesartan Medoxomil and Hydrochlorothiazide30 in 1 BOTTLETABLET3019
70756-813-51Olmesartan Medoxomil and Hydrochlorothiazide500 in 1 BOTTLETABLET50019
70756-813-90Olmesartan Medoxomil and Hydrochlorothiazide90 in 1 BOTTLETABLET9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-813-30EA - Each70756-813b3a29c9a-c7ad-4cb2-97d7-b889459947a412020-08-06
70756-813-90EA - Each70756-813d203f2d9-ff2c-4e1b-903e-04e15e82abf412020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-813OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET [LIFESTAR PHARMA LLC]17Current NDC, Legacy NDC, 4 package rows20241225_9771066e-c05d-6a93-e053-2995a90a7e87.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack77e71a2e-8370-4f7a-a5e4-93d86bd37dad2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208847
application number: ANDA208847
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDELifestar Pharma LLC9771066e-c05d-6a93-e053-2995a90a7e872025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208847
application number: ANDA208847
ndc (product): 70756-813
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsba452478-f40c-446e-b61d-388379a55efd2023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208847
application number: ANDA208847

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403854olmesartan medoxomil 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN77e71a2e-8370-4f7a-a5e4-93d86bd37dad104
403854hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD77e71a2e-8370-4f7a-a5e4-93d86bd37dad104
403854HCTZ 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY77e71a2e-8370-4f7a-a5e4-93d86bd37dad104
403853olmesartan medoxomil 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN9771066e-c05d-6a93-e053-2995a90a7e8719
403854olmesartan medoxomil 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN9771066e-c05d-6a93-e053-2995a90a7e8719
403855olmesartan medoxomil 40 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9771066e-c05d-6a93-e053-2995a90a7e8719
403853hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCD9771066e-c05d-6a93-e053-2995a90a7e8719
403854hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD9771066e-c05d-6a93-e053-2995a90a7e8719
403855hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD9771066e-c05d-6a93-e053-2995a90a7e8719
403853HCTZ 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSY9771066e-c05d-6a93-e053-2995a90a7e8719
403854HCTZ 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY9771066e-c05d-6a93-e053-2995a90a7e8719
403855HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY9771066e-c05d-6a93-e053-2995a90a7e8719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-813-12707560813121000 TABLET in 1 BOTTLE (70756-813-12) 1000 tablet2020-10-010000-00-00NoNoCurrent
70756-813-307075608133030 TABLET in 1 BOTTLE (70756-813-30) 30 tablet2020-10-010000-00-00NoNoCurrent
70756-813-5170756081351500 TABLET in 1 BOTTLE (70756-813-51) 500 tablet2020-10-01NoNoCurrent
70756-813-907075608139090 TABLET in 1 BOTTLE (70756-813-90) 90 tablet2020-10-010000-00-00NoNoCurrent