FDA.reportPublic FDA data

HYZAAR

Product NDC
78206-139
11-digit product format
782060139
Labeler code
78206
Product ID
78206-139_10ae5107-90f4-4e30-9320-da164ad71bb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Organon LLC
Application
NDA020387
Marketing category
NDA
Marketing start
2021-06-01
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
12.5; 50 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

Additional Listing Data#

Finished product
Yes
Brand name base
HYZAAR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
LOSARTAN POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A, 0J48LPH2TH
Rxcui979464, 979466, 979468, 979470, 979471, 979473

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
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
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
78206-139-01HYZAAR30 in 1 BOTTLETABLET, FILM COATED3010
78206-139-02HYZAAR90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-139-01EA - Each78206-13941a60558-7f1c-4649-8b08-0a432911c65612021-08-05
78206-139-02EA - Each78206-139e6b22618-dbbc-4569-8ab7-471a2d960f6312021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-139HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [ORGANON LLC]6Current NDC, Legacy NDC, 2 package rows20241113_4116ccde-2e23-45f4-b12f-6337df877744.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979466Hyzaar 100 MG / 12.5 MG Oral TabletPSN4116ccde-2e23-45f4-b12f-6337df87774410
979473Hyzaar 100 MG / 25 MG Oral TabletPSN4116ccde-2e23-45f4-b12f-6337df87774410
979470Hyzaar 50 MG / 12.5 MG Oral TabletPSN4116ccde-2e23-45f4-b12f-6337df87774410
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN4116ccde-2e23-45f4-b12f-6337df87774410
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN4116ccde-2e23-45f4-b12f-6337df87774410
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN4116ccde-2e23-45f4-b12f-6337df87774410
979466hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral Tablet [Hyzaar]SBD4116ccde-2e23-45f4-b12f-6337df87774410
979470hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral Tablet [Hyzaar]SBD4116ccde-2e23-45f4-b12f-6337df87774410
979473hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral Tablet [Hyzaar]SBD4116ccde-2e23-45f4-b12f-6337df87774410
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD4116ccde-2e23-45f4-b12f-6337df87774410
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCD4116ccde-2e23-45f4-b12f-6337df87774410
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCD4116ccde-2e23-45f4-b12f-6337df87774410
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979466HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet [Hyzaar]SY4116ccde-2e23-45f4-b12f-6337df87774410
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979470HCTZ 12.5 MG / Losartan K+ 50 MG Oral Tablet [Hyzaar]SY4116ccde-2e23-45f4-b12f-6337df87774410
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979466HCTZ 12.5 MG / Losartan Pot 100 MG Oral Tablet [Hyzaar]SY4116ccde-2e23-45f4-b12f-6337df87774410
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979470HCTZ 12.5 MG / Losartan Pot 50 MG Oral Tablet [Hyzaar]SY4116ccde-2e23-45f4-b12f-6337df87774410
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979473HCTZ 25 MG / Losartan K+ 100 MG Oral Tablet [Hyzaar]SY4116ccde-2e23-45f4-b12f-6337df87774410
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979473HCTZ 25 MG / Losartan Pot 100 MG Oral Tablet [Hyzaar]SY4116ccde-2e23-45f4-b12f-6337df87774410
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979466Hyzaar 100/12.5 Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979473Hyzaar 100/25 (hydrochlorothiazide 25 MG / losartan potassium 100 MG) Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979473Hyzaar 100/25 Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979470Hyzaar 50/12.5 (hydrochlorothiazide 12.5 MG / losartan potassium 50 MG) Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410
979470Hyzaar 50/12.5 Oral TabletSY4116ccde-2e23-45f4-b12f-6337df87774410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78206-139-017820601390130 TABLET, FILM COATED in 1 BOTTLE (78206-139-01) 2021-06-010000-00-00NoNoCurrent
78206-139-027820601390290 TABLET, FILM COATED in 1 BOTTLE (78206-139-02) 2021-06-010000-00-00NoNoCurrent