FDA.reportPublic FDA data

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Product NDC
49884-788
11-digit product format
498840788
Labeler code
49884
Product ID
49884-788_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; 25; 40 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
HYDROCHLOROTHIAZIDE25 mg/1
OLMESARTAN MEDOXOMIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, 864V2Q084H, 6M97XTV3HD
Rxcui999967, 999986, 999991, 999996, 1000001

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
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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
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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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-788-092022-09-27C16284748780-1e4f33bdf-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
49884-788-112022-09-27C16284748780-1e4f33bdf-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
49884-788-092022-07-29C16284748780-1e4f33bdf-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
49884-788-112022-07-29C16284748780-1e4f33bdf-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
49884-788-09olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9023
49884-788-11olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-788-09EA - Each49884-78838775c2c-92d0-47cd-86d1-4e2ceaaf76f612016-11-08
49884-788-11EA - Each49884-7889ebd6c8c-8c99-4601-8b4a-7bf988d70ea912016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-788OLMESARTAN 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
1000001olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNbe69f132-8b77-4590-a688-cb3709649466105
1000001amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCDbe69f132-8b77-4590-a688-cb3709649466105
1000001amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSYbe69f132-8b77-4590-a688-cb3709649466105
1000001Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSYbe69f132-8b77-4590-a688-cb3709649466105
1000001olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN49ec5ac8-a626-4ab2-9799-8a138920201e103
1000001amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD49ec5ac8-a626-4ab2-9799-8a138920201e103
1000001amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY49ec5ac8-a626-4ab2-9799-8a138920201e103
1000001Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY49ec5ac8-a626-4ab2-9799-8a138920201e103
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
1000001olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN57ffeef7-bfa8-4f92-aadc-23cd000226073
1000001amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD57ffeef7-bfa8-4f92-aadc-23cd000226073
1000001amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY57ffeef7-bfa8-4f92-aadc-23cd000226073
1000001Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY57ffeef7-bfa8-4f92-aadc-23cd000226073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-788-094988407880990 TABLET, FILM COATED in 1 BOTTLE (49884-788-09) 2016-10-260000-00-00NoNoCurrent
49884-788-114988407881130 TABLET, FILM COATED in 1 BOTTLE (49884-788-11) 2016-10-260000-00-00NoNoCurrent