Losartan Potassium and Hydrochlorothiazide

Product NDC
21695-966
11-digit product format
216950966
Labeler code
21695
Product ID
21695-966_80ed0406-cf05-423e-b5e7-4e544a88b0ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA090528
Marketing category
ANDA
Marketing start
2010-04-06
Marketing end
0000-00-00
Substance
LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
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1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
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55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
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59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
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f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-966-302019-09-24C16284748780-1934fe258-4ae8-48b1-e053-8cdaa90a720aLosartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-966-30Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-966-30EA - Each21695-966650213b5-669c-4913-86cc-f4ded1a0578c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-966LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20111118_80ed0406-cf05-423e-b5e7-4e544a88b0ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN80ed0406-cf05-423e-b5e7-4e544a88b0ed1
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD80ed0406-cf05-423e-b5e7-4e544a88b0ed1
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY80ed0406-cf05-423e-b5e7-4e544a88b0ed1
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY80ed0406-cf05-423e-b5e7-4e544a88b0ed1
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY80ed0406-cf05-423e-b5e7-4e544a88b0ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-966-302169509663030 in 1 BOTTLEHistorical