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VERAPAMIL HYDROCHLORIDE

Approved
Approval ID

5501208c-aa2b-47aa-89f7-87f4d4a73fd0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 19, 2022

Manufacturers
FDA

Cadila Pharmaceuticals Limited

DUNS: 862257719

Products 3

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 Code71209-048
Application NumberANDA206173
Product Classification
M
Marketing Category
C73584
G
Generic Name
verapamil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2022
FDA Product Classification

INGREDIENTS (12)

VERAPAMIL HYDROCHLORIDEActive
Quantity: 240 mg in 1 1
Code: V3888OEY5R
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

verapamil hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71209-104
Application NumberANDA206173
Product Classification
M
Marketing Category
C73584
G
Generic Name
verapamil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2022
FDA Product Classification

INGREDIENTS (12)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VERAPAMIL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: V3888OEY5R
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT

verapamil hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71209-047
Application NumberANDA206173
Product Classification
M
Marketing Category
C73584
G
Generic Name
verapamil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2022
FDA Product Classification

INGREDIENTS (12)

VERAPAMIL HYDROCHLORIDEActive
Quantity: 180 mg in 1 1
Code: V3888OEY5R
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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VERAPAMIL HYDROCHLORIDE - FDA Drug Approval Details