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Verapamil Hydrochloride

VERAPAMIL HCl EXTENDED-RELEASE TABLETS USPRx only

Approved
Approval ID

4eb349bb-c46b-4809-81af-6f924a5e34ef

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 19, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 2

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

Verapamil Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53808-0324
Application NumberNDA019152
Product Classification
M
Marketing Category
C73594
G
Generic Name
Verapamil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification

INGREDIENTS (11)

VERAPAMIL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: V3888OEY5R
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

Verapamil Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53808-0972
Application NumberNDA019152
Product Classification
M
Marketing Category
C73594
G
Generic Name
Verapamil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification

INGREDIENTS (10)

VERAPAMIL HYDROCHLORIDEActive
Quantity: 240 mg in 1 1
Code: V3888OEY5R
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT

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Verapamil Hydrochloride - FDA Drug Approval Details