TAZTIA

TAZTIA XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) ONCE-A-DAY-DOSAGE

Approved

Approval ID

c9f74c57-3fe9-470b-9096-31d0acb22f7e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 25, 2022

Manufacturers

FDA

Actavis Pharma, Inc.

DUNS: 119723554

Products 5

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 Code62037-700

Application NumberANDA075401

Product Classification

Marketing Category

C73584

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJuly 25, 2022

FDA Product Classification

INGREDIENTS (20)

DILTIAZEM HYDROCHLORIDEActive

Quantity: 360 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

ETHYLCELLULOSE (10 MPA.S)Inactive

Code: 3DYK7UYZ62

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

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

Code: P2OM2Q86BI

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

NONOXYNOL-100Inactive

Code: A906T4D368

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code62037-699

Application NumberANDA075401

Product Classification

Marketing Category

C73584

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJuly 25, 2022

FDA Product Classification

INGREDIENTS (22)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 300 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ETHYLCELLULOSE (10 MPA.S)Inactive

Code: 3DYK7UYZ62

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

NONOXYNOL-100Inactive

Code: A906T4D368

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

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

Code: P2OM2Q86BI

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code62037-696

Application NumberANDA075401

Product Classification

Marketing Category

C73584

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJuly 25, 2022

FDA Product Classification

INGREDIENTS (21)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ETHYLCELLULOSE (10 MPA.S)Inactive

Code: 3DYK7UYZ62

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 120 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

NONOXYNOL-100Inactive

Code: A906T4D368

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

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

Code: P2OM2Q86BI

Classification: IACT

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code62037-698

Application NumberANDA075401

Product Classification

Marketing Category

C73584

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJuly 25, 2022

FDA Product Classification

INGREDIENTS (21)

GELATINInactive

Code: 2G86QN327L

Classification: IACT

NONOXYNOL-100Inactive

Code: A906T4D368

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

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

Code: P2OM2Q86BI

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 240 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ETHYLCELLULOSE (10 MPA.S)Inactive

Code: 3DYK7UYZ62

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code62037-697

Application NumberANDA075401

Product Classification

Marketing Category

C73584

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJuly 25, 2022

FDA Product Classification

INGREDIENTS (21)

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 180 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ETHYLCELLULOSE (10 MPA.S)Inactive

Code: 3DYK7UYZ62

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

NONOXYNOL-100Inactive

Code: A906T4D368

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

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

Code: P2OM2Q86BI

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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TAZTIA

Products 5

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (22)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

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