FDA.reportPublic FDA data

Losartan Potassium and Hydrochlorothiazide

Product NDC
59746-338
11-digit product format
597460338
Labeler code
59746
Product ID
59746-338_5357e5cd-0f2e-4296-8879-72e700f87d46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA201845
Marketing category
ANDA
Marketing start
2012-10-30
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
12.5; 100 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
Losartan Potassium and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
LOSARTAN POTASSIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A, 0J48LPH2TH
Rxcui979464, 979468, 979471

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
59746-338-01Losartan Potassium and Hydrochlorothiazide100 in 1 BOTTLETABLET, FILM COATED10014
59746-338-10Losartan Potassium and Hydrochlorothiazide1000 in 1 BOTTLETABLET, FILM COATED100014
59746-338-30Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3014
59746-338-90Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-338-30EA - Each59746-3385b167692-6bee-4253-b71a-c133ef2ddb3812013-08-02
59746-338-90EA - Each59746-3382a4cc18c-95f4-44c0-a219-288df6aee78d12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydrochlorothiazideACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
losartan potassiumACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
HydrochlorothiazideACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
LosartanACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
Aluminum OxideINACTIVE INGREDIENTLMI26O6933LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
HypromellosesINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
magnesium stearateINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
Starch, CornINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-338LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 4 package rows20231219_e0b74a86-3d36-1af0-e538-41b45b8d2cc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN0e015b9a-0ac1-4ec3-bbe7-7a672d30e1f4104
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD0e015b9a-0ac1-4ec3-bbe7-7a672d30e1f4104
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY0e015b9a-0ac1-4ec3-bbe7-7a672d30e1f4104
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY0e015b9a-0ac1-4ec3-bbe7-7a672d30e1f4104
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY0e015b9a-0ac1-4ec3-bbe7-7a672d30e1f4104
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN1d6712a3-bfb3-4081-b8f6-6057eb4baa27102
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD1d6712a3-bfb3-4081-b8f6-6057eb4baa27102
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY1d6712a3-bfb3-4081-b8f6-6057eb4baa27102
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY1d6712a3-bfb3-4081-b8f6-6057eb4baa27102
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY1d6712a3-bfb3-4081-b8f6-6057eb4baa27102
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCDe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCDe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSYe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSYe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSYe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSYe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSYe0b74a86-3d36-1af0-e538-41b45b8d2cc314
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN1bb08103-04ee-47a6-a9ad-290e169feb517
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD1bb08103-04ee-47a6-a9ad-290e169feb517
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY1bb08103-04ee-47a6-a9ad-290e169feb517
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY1bb08103-04ee-47a6-a9ad-290e169feb517
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY1bb08103-04ee-47a6-a9ad-290e169feb517
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe78b2195-a2da-3d03-e053-2a95a90a7d563
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNe78b2195-a2da-3d03-e053-2a95a90a7d563
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe78b2195-a2da-3d03-e053-2a95a90a7d563
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDe78b2195-a2da-3d03-e053-2a95a90a7d563
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCDe78b2195-a2da-3d03-e053-2a95a90a7d563
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCDe78b2195-a2da-3d03-e053-2a95a90a7d563
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYe78b2195-a2da-3d03-e053-2a95a90a7d563
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSYe78b2195-a2da-3d03-e053-2a95a90a7d563
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYe78b2195-a2da-3d03-e053-2a95a90a7d563
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSYe78b2195-a2da-3d03-e053-2a95a90a7d563
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYe78b2195-a2da-3d03-e053-2a95a90a7d563
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSYe78b2195-a2da-3d03-e053-2a95a90a7d563
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSYe78b2195-a2da-3d03-e053-2a95a90a7d563
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSYe78b2195-a2da-3d03-e053-2a95a90a7d563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-338-0159746033801100 TABLET, FILM COATED in 1 BOTTLE (59746-338-01) 2012-10-300000-00-00NoNoCurrent
59746-338-10597460338101000 TABLET, FILM COATED in 1 BOTTLE (59746-338-10) 2012-10-300000-00-00NoNoCurrent
59746-338-305974603383030 TABLET, FILM COATED in 1 BOTTLE (59746-338-30) 2012-10-300000-00-00NoNoCurrent
59746-338-905974603389090 TABLET, FILM COATED in 1 BOTTLE (59746-338-90) 2012-10-300000-00-00NoNoCurrent