FDA.reportPublic FDA data

Losartan potassium and Hydrochlorothiazide

Product NDC
33342-051
11-digit product format
333420051
Labeler code
33342
Product ID
33342-051_cf31d31e-9355-47da-9c2b-8e4b84ac8159
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan potassium and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202289
Marketing category
ANDA
Marketing start
2012-05-03
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
33342-051-07Losartan potassium and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3012
33342-051-10Losartan potassium and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9012
33342-051-12Losartan potassium and Hydrochlorothiazide10 in 1 BLISTER PACKTABLET, FILM COATED1012
33342-051-12Losartan potassium and Hydrochlorothiazide10 in 1 CARTONTABLET, FILM COATED1012
33342-051-44Losartan potassium and Hydrochlorothiazide1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-051-07EA - Each33342-051d6ccf35a-e68b-4eca-94cc-be07d81d267b12015-04-03
33342-051-10EA - Each33342-05126c4aa9e-04e4-49c2-ae28-3afe47b0007112015-04-03
33342-051-44EA - Each33342-0513748ec37-d6b9-4d89-8cb1-887febcd541f12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-051LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]11Current NDC, Legacy NDC, 5 package rows20230425_a04b5622-2c49-4d61-92b1-5dc523af7a24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNf5f462c6-0604-49d3-af8f-fecbde23be99100
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDf5f462c6-0604-49d3-af8f-fecbde23be99100
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYf5f462c6-0604-49d3-af8f-fecbde23be99100
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYf5f462c6-0604-49d3-af8f-fecbde23be99100
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYf5f462c6-0604-49d3-af8f-fecbde23be99100
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNa04b5622-2c49-4d61-92b1-5dc523af7a2412
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNa04b5622-2c49-4d61-92b1-5dc523af7a2412
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNa04b5622-2c49-4d61-92b1-5dc523af7a2412
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDa04b5622-2c49-4d61-92b1-5dc523af7a2412
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCDa04b5622-2c49-4d61-92b1-5dc523af7a2412
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCDa04b5622-2c49-4d61-92b1-5dc523af7a2412
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYa04b5622-2c49-4d61-92b1-5dc523af7a2412
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSYa04b5622-2c49-4d61-92b1-5dc523af7a2412
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYa04b5622-2c49-4d61-92b1-5dc523af7a2412
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSYa04b5622-2c49-4d61-92b1-5dc523af7a2412
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYa04b5622-2c49-4d61-92b1-5dc523af7a2412
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSYa04b5622-2c49-4d61-92b1-5dc523af7a2412
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSYa04b5622-2c49-4d61-92b1-5dc523af7a2412
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSYa04b5622-2c49-4d61-92b1-5dc523af7a2412
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd1ee193e-bf78-3134-e053-2a95a90a65d22
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN352061ee-942d-6cba-e063-6294a90a9eea2
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDd1ee193e-bf78-3134-e053-2a95a90a65d22
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD352061ee-942d-6cba-e063-6294a90a9eea2
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYd1ee193e-bf78-3134-e053-2a95a90a65d22
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY352061ee-942d-6cba-e063-6294a90a9eea2
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYd1ee193e-bf78-3134-e053-2a95a90a65d22
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY352061ee-942d-6cba-e063-6294a90a9eea2
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYd1ee193e-bf78-3134-e053-2a95a90a65d22
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY352061ee-942d-6cba-e063-6294a90a9eea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-051-073334200510730 TABLET, FILM COATED in 1 BOTTLE (33342-051-07) 2012-09-100000-00-00NoNoCurrent
33342-051-103334200511090 TABLET, FILM COATED in 1 BOTTLE (33342-051-10) 2012-09-100000-00-00NoNoCurrent
33342-051-123334200511210 BLISTER PACK in 1 CARTON (33342-051-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-09-100000-00-00NoNoCurrent
33342-051-44333420051441000 TABLET, FILM COATED in 1 BOTTLE (33342-051-44) 2012-09-100000-00-00NoNoCurrent