FDA.reportPublic FDA data

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Product NDC
49884-786
11-digit product format
498840786
Labeler code
49884
Product ID
49884-786_9ce53e8f-235a-4ebc-b1b1-4e764daacab2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA206137
Marketing category
ANDA
Marketing start
2016-10-26
Substance
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
5; 12.5; 20 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD, 864V2Q084H, 0J48LPH2TH
Rxcui999967, 999986, 999991, 999996, 1000001

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
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ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
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df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-786-092022-09-27C16284748780-1e4f33bdf-ab0f-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010
49884-786-112022-09-27C16284748780-1e4f33bdf-ab0f-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010
49884-786-092022-07-29C16284748780-1e4f33bdf-ab0f-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010
49884-786-112022-07-29C16284748780-1e4f33bdf-ab0f-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-786-09olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9023
49884-786-11olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-786OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ENDO USA, INC.]21Current NDC, Legacy NDC, 2 package rows20250426_268d12e8-1cfc-4086-b613-8fd94f2d7c4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999967olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN204592ba-a68f-452a-9987-1b33b7b6c4d5105
999967amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCD204592ba-a68f-452a-9987-1b33b7b6c4d5105
999967amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSY204592ba-a68f-452a-9987-1b33b7b6c4d5105
999967Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral TabletSY204592ba-a68f-452a-9987-1b33b7b6c4d5105
999967olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN44dc874b-4377-46eb-ae32-8d84c9c4d4ae103
999967amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCD44dc874b-4377-46eb-ae32-8d84c9c4d4ae103
999967amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSY44dc874b-4377-46eb-ae32-8d84c9c4d4ae103
999967Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral TabletSY44dc874b-4377-46eb-ae32-8d84c9c4d4ae103
999967olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNb404a550-0df4-404a-8d10-c35e197ca399101
999967amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCDb404a550-0df4-404a-8d10-c35e197ca399101
999967amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSYb404a550-0df4-404a-8d10-c35e197ca399101
999967Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral TabletSYb404a550-0df4-404a-8d10-c35e197ca399101
999967olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999986olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999991olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999996olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
1000001olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999986amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999991amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999967amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCD268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999996amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
1000001amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999991amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
1000001amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999996amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999986amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999967amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999986Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999991Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999967Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
999996Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23
1000001Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY268d12e8-1cfc-4086-b613-8fd94f2d7c4e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-786-094988407860990 TABLET, FILM COATED in 1 BOTTLE (49884-786-09) 2016-10-260000-00-00NoNoCurrent
49884-786-114988407861130 TABLET, FILM COATED in 1 BOTTLE (49884-786-11) 2016-10-260000-00-00NoNoCurrent