Valsartan and Hydrochlorothiazide
These highlights do not include all the information needed to use VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN and HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
27343b81-03fb-4ccf-80b2-53ac086fefe7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valsartan and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-2785
Application NumberANDA203145
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valsartan and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2022
FDA Product Classification
INGREDIENTS (12)
VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT