Diltiazem Hydrochloride

Diltiazem Hydrochloride Extended-Release Capsules

Approved

Approval ID

9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 18, 2019

Manufacturers

FDA

PuraCap Laboratories LLC

DUNS: 080210964

Products 6

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

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code24658-170

Application NumberNDA020401

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 8, 2019

FDA Product Classification

INGREDIENTS (16)

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive

Code: P2OM2Q86BI

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 120 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

SUCROSE STEARATEInactive

Code: 274KW0O50M

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code24658-173

Application NumberNDA020401

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 8, 2019

FDA Product Classification

INGREDIENTS (16)

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive

Code: P2OM2Q86BI

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SUCROSE STEARATEInactive

Code: 274KW0O50M

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 300 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code24658-172

Application NumberNDA020401

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 8, 2019

FDA Product Classification

INGREDIENTS (16)

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive

Code: P2OM2Q86BI

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SUCROSE STEARATEInactive

Code: 274KW0O50M

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 240 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code24658-346

Application NumberNDA020401

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 8, 2019

FDA Product Classification

INGREDIENTS (16)

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive

Code: P2OM2Q86BI

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SUCROSE STEARATEInactive

Code: 274KW0O50M

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 420 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code24658-174

Application NumberNDA020401

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 8, 2019

FDA Product Classification

INGREDIENTS (16)

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive

Code: P2OM2Q86BI

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SUCROSE STEARATEInactive

Code: 274KW0O50M

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 360 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code24658-171

Application NumberNDA020401

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 8, 2019

FDA Product Classification

INGREDIENTS (16)

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive

Code: P2OM2Q86BI

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

SUCROSE STEARATEInactive

Code: 274KW0O50M

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 180 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

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Diltiazem Hydrochloride

Products 6

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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