Losartan Potassium and Hydrochlorothiazide

Product NDC
13668-117
11-digit product format
136680117
Labeler code
13668
Product ID
13668-117_dbd94079-ffe8-5fc3-e053-2995a90a518e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA090528
Marketing category
ANDA
Marketing start
2010-04-06
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
13 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
2023-12-31
Current FDA listing
Historical FDA.report record

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
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1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
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55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
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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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-117-10EA - Each13668-117a3884645-0d14-4755-96f0-3c5993700d8312012-07-24
13668-117-30EA - Each13668-117e5c21d92-7da5-4e2b-bf14-95a3ff33111612012-07-24
13668-117-90EA - Each13668-1175d4a9e4c-1a15-4202-9b79-43443d1a481e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]2
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]2
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [DISPENSING SOLUTIONS, INC.]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [DISPENSING SOLUTIONS, INC.]1
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [DISPENSING SOLUTIONS, INC.]1
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [DISPENSING SOLUTIONS, INC.]1
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN982c6ccb-f0b2-4e77-8e05-d9f8213007406
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD982c6ccb-f0b2-4e77-8e05-d9f8213007406
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY982c6ccb-f0b2-4e77-8e05-d9f8213007406
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY982c6ccb-f0b2-4e77-8e05-d9f8213007406
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY982c6ccb-f0b2-4e77-8e05-d9f8213007406
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN80ed0406-cf05-423e-b5e7-4e544a88b0ed1
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN9ec40f6f-209c-4ed7-baef-00604e7370a91
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD80ed0406-cf05-423e-b5e7-4e544a88b0ed1
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD9ec40f6f-209c-4ed7-baef-00604e7370a91
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY80ed0406-cf05-423e-b5e7-4e544a88b0ed1
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY9ec40f6f-209c-4ed7-baef-00604e7370a91
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY80ed0406-cf05-423e-b5e7-4e544a88b0ed1
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY9ec40f6f-209c-4ed7-baef-00604e7370a91
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY80ed0406-cf05-423e-b5e7-4e544a88b0ed1
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY9ec40f6f-209c-4ed7-baef-00604e7370a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-117-10136680117101000 TABLET in 1 BOTTLE (13668-117-10) 1000 tablet2010-10-060000-00-00NoNoCurrent
13668-117-301366801173030 TABLET in 1 BOTTLE (13668-117-30) 30 tablet2010-10-060000-00-00NoNoCurrent
13668-117-7413668011774100 TABLET in 1 CARTON (13668-117-74) 100 tablet2010-10-060000-00-00NoNoCurrent
13668-117-901366801179090 TABLET in 1 BOTTLE (13668-117-90) 90 tablet2010-10-060000-00-00NoNoCurrent