FDA.reportPublic FDA data

Losartan Potassium and Hydrochlorothiazide

Product NDC
68180-216
11-digit product format
681800216
Labeler code
68180
Product ID
68180-216_6b0e9bc3-30a9-47ce-8cbe-c51404d51ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078245
Marketing category
ANDA
Marketing start
2010-10-06
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
Unii0J48LPH2TH, 3ST302B24A
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
89dac932-b90a-4410-9ab1-84c53e57de25Product 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
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-216-01Losartan Potassium and Hydrochlorothiazide100 in 1 BOTTLETABLET10022
68180-216-03Losartan Potassium and Hydrochlorothiazide1000 in 1 BOTTLETABLET100022
68180-216-06Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLETABLET3022
68180-216-09Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLETABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-216-03EA - Each68180-2164d121027-4db8-4b8b-a12d-f093e74c102012012-07-24
68180-216-06EA - Each68180-216d4b3d9ae-f796-4914-b991-37c034312c5b12012-07-24
68180-216-09EA - Each68180-216336578d8-715e-4f21-9e41-115195c3cd3212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-216LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 4 package rows20250513_ee1eaaf6-050b-48af-942b-5e3451edc164.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNee1eaaf6-050b-48af-942b-5e3451edc16422
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNee1eaaf6-050b-48af-942b-5e3451edc16422
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNee1eaaf6-050b-48af-942b-5e3451edc16422
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDee1eaaf6-050b-48af-942b-5e3451edc16422
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCDee1eaaf6-050b-48af-942b-5e3451edc16422
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCDee1eaaf6-050b-48af-942b-5e3451edc16422
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYee1eaaf6-050b-48af-942b-5e3451edc16422
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSYee1eaaf6-050b-48af-942b-5e3451edc16422
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYee1eaaf6-050b-48af-942b-5e3451edc16422
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSYee1eaaf6-050b-48af-942b-5e3451edc16422
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYee1eaaf6-050b-48af-942b-5e3451edc16422
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSYee1eaaf6-050b-48af-942b-5e3451edc16422
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSYee1eaaf6-050b-48af-942b-5e3451edc16422
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSYee1eaaf6-050b-48af-942b-5e3451edc16422
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN8de04bf2-83dd-c494-e053-2a95a90abade14
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN8de04bf2-83dd-c494-e053-2a95a90abade14
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN8de04bf2-83dd-c494-e053-2a95a90abade14
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD8de04bf2-83dd-c494-e053-2a95a90abade14
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCD8de04bf2-83dd-c494-e053-2a95a90abade14
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCD8de04bf2-83dd-c494-e053-2a95a90abade14
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY8de04bf2-83dd-c494-e053-2a95a90abade14
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSY8de04bf2-83dd-c494-e053-2a95a90abade14
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY8de04bf2-83dd-c494-e053-2a95a90abade14
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSY8de04bf2-83dd-c494-e053-2a95a90abade14
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY8de04bf2-83dd-c494-e053-2a95a90abade14
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSY8de04bf2-83dd-c494-e053-2a95a90abade14
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSY8de04bf2-83dd-c494-e053-2a95a90abade14
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSY8de04bf2-83dd-c494-e053-2a95a90abade14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-216-0168180021601100 TABLET in 1 BOTTLE (68180-216-01) 100 tablet2010-10-060000-00-00NoNoCurrent
68180-216-03681800216031000 TABLET in 1 BOTTLE (68180-216-03) 1000 tablet2010-10-060000-00-00NoNoCurrent
68180-216-066818002160630 TABLET in 1 BOTTLE (68180-216-06) 30 tablet2010-10-060000-00-00NoNoCurrent
68180-216-096818002160990 TABLET in 1 BOTTLE (68180-216-09) 90 tablet2010-10-060000-00-00NoNoCurrent