FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE

Product NDC
42571-245
11-digit product format
425710245
Labeler code
42571
Product ID
42571-245_44b62ded-18e8-b2e8-e063-6294a90ac180
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil, Amlodipine besylate and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA207437
Marketing category
ANDA
Marketing start
2026-03-01
Substance
OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Active strength
20; 5; 12.5 mg/1; mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], 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 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207437-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2025-11-24
A207437-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-24
A207437-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;25MG;40MGTABLET / ORALAB2025-11-24
A207437-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-24
A207437-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 10MG BASE;25MG;40MGTABLET / ORALAB2025-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A207437-001AB
A207437-002AB
A207437-003AB
A207437-004AB
A207437-005AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207437-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2025-11-2484e616aacf4f…
2026-09-14 22:38:342026-08A207437-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-2484e616aacf4f…
2026-09-14 22:38:342026-08A207437-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2025-11-2484e616aacf4f…
2026-09-14 22:38:342026-08A207437-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-2484e616aacf4f…
2026-09-14 22:38:342026-08A207437-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2025-11-2484e616aacf4f…
2026-08-18 06:07:402026-07A207437-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2025-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07A207437-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07A207437-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2025-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07A207437-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07A207437-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2025-11-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207437-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2025-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207437-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207437-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2025-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207437-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207437-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2025-11-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2025-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2025-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2025-11-2431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2025-11-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2025-11-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2025-11-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2025-11-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207437-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207437-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207437-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A207437-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A207437-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A207437-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207437-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207437-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207437-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207437-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207437-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207437-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207437-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207437-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207437-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207437-005AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207437-005AB1a50c72e98297…

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, AMLODIPINE and HYDROCHLOROTHIAZIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL20 mg/1
AMLODIPINE BESYLATE5 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864V2Q084HInternal UNII lookup
6M97XTV3HDInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
999967Internal RxNorm lookup
999986Internal RxNorm lookup
999991Internal RxNorm lookup
999996Internal RxNorm lookup
1000001Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9fb71df8-f70f-47dc-9465-8d8748261cafAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
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
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product 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
42571-245-05OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE500 in 1 BOTTLETABLET, FILM COATED5005
42571-245-10OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE1000 in 1 BOTTLETABLET, FILM COATED10005
42571-245-30OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET, FILM COATED305
42571-245-90OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET, FILM COATED905

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDEMicro Labs Limited9fb71df8-f70f-47dc-9465-8d8748261caf2025-11-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207437
application number: ANDA207437
ndc (product): 42571-245

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999967olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN9fb71df8-f70f-47dc-9465-8d8748261caf5
999986olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN9fb71df8-f70f-47dc-9465-8d8748261caf5
999991olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9fb71df8-f70f-47dc-9465-8d8748261caf5
999996olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN9fb71df8-f70f-47dc-9465-8d8748261caf5
1000001olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9fb71df8-f70f-47dc-9465-8d8748261caf5
999986amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD9fb71df8-f70f-47dc-9465-8d8748261caf5
999991amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD9fb71df8-f70f-47dc-9465-8d8748261caf5
999967amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCD9fb71df8-f70f-47dc-9465-8d8748261caf5
999996amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD9fb71df8-f70f-47dc-9465-8d8748261caf5
1000001amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD9fb71df8-f70f-47dc-9465-8d8748261caf5
999991amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5
1000001amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5
999996amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5
999986amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5
999967amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5
999986Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5
999991Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5
999967Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5
999996Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5
1000001Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY9fb71df8-f70f-47dc-9465-8d8748261caf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42571-245-0542571024505500 TABLET, FILM COATED in 1 BOTTLE (42571-245-05) 2026-03-01NoNoCurrent
42571-245-10425710245101000 TABLET, FILM COATED in 1 BOTTLE (42571-245-10) 2026-03-01NoNoCurrent
42571-245-304257102453030 TABLET, FILM COATED in 1 BOTTLE (42571-245-30) 2026-03-01NoNoCurrent
42571-245-904257102459090 TABLET, FILM COATED in 1 BOTTLE (42571-245-90) 2026-03-01NoNoCurrent