Losartan Potassium and Hydrochlorothiazide

Product NDC
33261-904
11-digit product format
332610904
Labeler code
33261
Product ID
33261-904_b125e99c-f968-4ece-9c23-64aa5b1e4986
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077732
Marketing category
ANDA
Marketing start
2010-10-06
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
No
Listing certified through
2019-12-31
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
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96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
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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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-904-30Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLE, PLASTICTABLET301
33261-904-90Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-904-30EA - Each33261-904e2fbcdce-1192-4b41-9c3e-d3517c3a752e12015-10-02
33261-904-90EA - Each33261-904e5efa923-af4f-4c9b-b5f8-c1eef229596112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-904LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140128_c5de8851-986c-4f0c-9262-556bee0b48c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNc5de8851-986c-4f0c-9262-556bee0b48c01
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCDc5de8851-986c-4f0c-9262-556bee0b48c01
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSYc5de8851-986c-4f0c-9262-556bee0b48c01
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSYc5de8851-986c-4f0c-9262-556bee0b48c01
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSYc5de8851-986c-4f0c-9262-556bee0b48c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-904-303326109043030 in 1 BOTTLE, PLASTICHistorical
33261-904-903326109049090 in 1 BOTTLE, PLASTICHistorical