FDA.reportPublic FDA data

Losartan Potassium and Hydrochlorothiazide

Product NDC
0093-7368
11-digit product format
000937368
Labeler code
0093
Product ID
0093-7368_3fa33b06-383d-42a5-9349-35d3bdf9ab30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077157
Marketing category
ANDA
Marketing start
2010-04-06
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
25; 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium and Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 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
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
0093-7368-10Losartan Potassium and Hydrochlorothiazide1000 in 1 BOTTLETABLET, FILM COATED100026
0093-7368-56Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3026
0093-7368-98Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7368-10EA - Each0093-73684392efb3-7f11-49f7-94ae-a36c2cea4b5f12012-07-24
0093-7368-56EA - Each0093-73683c7dbe14-ccbb-467c-bece-4f29c231976e12012-07-24
0093-7368-98EA - Each0093-7368136c90b2-deae-4abd-87a3-be113d08734e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7368LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]24Current NDC, Legacy NDC, 3 package rows20231222_deafd195-7a1b-4ad8-a371-2cd9f433dea5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCDdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCDdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSYdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSYdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSYdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSYdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSYdeafd195-7a1b-4ad8-a371-2cd9f433dea526
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN72c97b7f-d945-5106-e053-2a91aa0a9b3b6
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCD72c97b7f-d945-5106-e053-2a91aa0a9b3b6
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSY72c97b7f-d945-5106-e053-2a91aa0a9b3b6
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSY72c97b7f-d945-5106-e053-2a91aa0a9b3b6
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSY72c97b7f-d945-5106-e053-2a91aa0a9b3b6
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN8d992a4c-8740-4636-928f-bb808eae33365
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCD8d992a4c-8740-4636-928f-bb808eae33365
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSY8d992a4c-8740-4636-928f-bb808eae33365
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSY8d992a4c-8740-4636-928f-bb808eae33365
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSY8d992a4c-8740-4636-928f-bb808eae33365
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN76678031-5373-498b-b59d-195705e6ac694
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN76678031-5373-498b-b59d-195705e6ac694
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN76678031-5373-498b-b59d-195705e6ac694
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD76678031-5373-498b-b59d-195705e6ac694
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCD76678031-5373-498b-b59d-195705e6ac694
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCD76678031-5373-498b-b59d-195705e6ac694
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY76678031-5373-498b-b59d-195705e6ac694
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSY76678031-5373-498b-b59d-195705e6ac694
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY76678031-5373-498b-b59d-195705e6ac694
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSY76678031-5373-498b-b59d-195705e6ac694
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY76678031-5373-498b-b59d-195705e6ac694
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSY76678031-5373-498b-b59d-195705e6ac694
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSY76678031-5373-498b-b59d-195705e6ac694
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSY76678031-5373-498b-b59d-195705e6ac694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7368-10000937368101000 TABLET, FILM COATED in 1 BOTTLE (0093-7368-10) 2010-04-060000-00-00NoNoCurrent
0093-7368-560009373685630 TABLET, FILM COATED in 1 BOTTLE (0093-7368-56) 2010-04-060000-00-00NoNoCurrent
0093-7368-980009373689890 TABLET, FILM COATED in 1 BOTTLE (0093-7368-98) 2010-04-060000-00-00NoNoCurrent