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Losartan Potassium and Hydrochlorothiazide

Losartan Potassium and Hydrochlorothiazide Tablets USP

Approved
Approval ID

c5de8851-986c-4f0c-9262-556bee0b48c0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 11, 2014

Manufacturers
FDA

Aidarex Pharmaceuticals LLC

DUNS: 801503249

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Losartan Potassium and Hydrochlorothiazide

PRODUCT DETAILS

NDC Product Code33261-904
Application NumberANDA077732
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 11, 2014
Generic NameLosartan Potassium and Hydrochlorothiazide

INGREDIENTS (13)

HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 100 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
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