AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE.AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral useInitial U.S. Approval: 2009
Approved
Approval ID
9b76e441-e6a5-4036-8276-b7788ade5c44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2022
Manufacturers
FDA
Strides Pharma Science Limited
DUNS: 650738743
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amlodipine besylate valsartan hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-199
Application NumberANDA201087
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate valsartan hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2022
FDA Product Classification
INGREDIENTS (12)
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
amlodipine besylate valsartan hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-201
Application NumberANDA201087
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate valsartan hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2022
FDA Product Classification
INGREDIENTS (13)
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
VALSARTANActive
Quantity: 320 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
amlodipine besylate valsartan hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-198
Application NumberANDA201087
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate valsartan hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2022
FDA Product Classification
INGREDIENTS (12)
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
amlodipine besylate valsartan hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-200
Application NumberANDA201087
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate valsartan hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2022
FDA Product Classification
INGREDIENTS (10)
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
amlodipine besylate valsartan hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-197
Application NumberANDA201087
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate valsartan hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2022
FDA Product Classification
INGREDIENTS (15)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MY
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT