FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product NDC
70518-4577
11-digit product format
705184577
Labeler code
70518
Product ID
70518-4577_5baf9a88-d4ab-2513-e063-6394a90a0187
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207037
Marketing category
ANDA
Marketing start
2026-02-27
Substance
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength
40; 25 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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207037-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-11
A207037-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-11
A207037-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207037-001AB
A207037-002AB
A207037-003AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207037-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2024-07-1184e616aacf4f…
2026-09-14 22:38:342026-08A207037-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2024-07-1184e616aacf4f…
2026-09-14 22:38:342026-08A207037-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2024-07-1184e616aacf4f…
2026-08-18 06:07:402026-07A207037-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2024-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207037-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2024-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207037-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2024-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207037-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2024-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207037-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2024-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207037-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2024-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207037-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2024-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207037-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2024-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207037-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2024-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207037-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207037-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207037-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207037-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207037-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207037-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207037-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207037-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207037-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207037-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207037-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207037-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207037-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207037-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207037-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207037-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207037-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207037-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207037-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207037-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207037-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207037-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A207037-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A207037-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207037-001HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2024-07-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207037-002HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2024-07-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207037-003HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2024-07-1179d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207037-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2024-07-11a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207037-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207037-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207037-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A207037-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207037-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207037-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207037-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207037-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207037-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207037-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207037-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207037-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207037-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207037-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207037-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207037-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207037-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207037-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207037-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207037-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207037-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207037-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207037-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207037-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207037-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207037-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207037-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207037-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207037-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207037-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207037-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207037-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207037-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207037-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207037-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207037-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207037-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207037-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207037-003AB179d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207037-001AB1a50c72e98297…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL40 mg/1
HYDROCHLOROTHIAZIDE25 mg/1

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
70518-4577-0OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403855olmesartan medoxomil 40 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9c68d45d-e4c8-4f6f-9ca5-faadc056e6e71
403855hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD9c68d45d-e4c8-4f6f-9ca5-faadc056e6e71
403855HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY9c68d45d-e4c8-4f6f-9ca5-faadc056e6e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4577-07051845770090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4577-0) 2026-02-27NoNoCurrent