Diltiazem Hydrochloride

Diltiazem Hydrochloride Extended-Release Capsules, USP Rx Only

Approved

Approval ID

a66ad880-cdab-435a-a6f2-574cfdfd1ac3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2023

Manufacturers

FDA

Par Pharmaceutical, Inc.

DUNS: 092733690

Products 4

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 Code10370-829

Application NumberANDA074984

Product Classification

Marketing Category

C73584

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 21, 2023

FDA Product Classification

INGREDIENTS (15)

AMMONIO METHACRYLATE COPOLYMER TYPE AInactive

Code: 8GQS4E66YY

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DILTIAZEM HYDROCHLORIDEActive

Quantity: 120 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10370-831

Application NumberANDA074984

Product Classification

Marketing Category

C73584

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 21, 2023

FDA Product Classification

INGREDIENTS (17)

DILTIAZEM HYDROCHLORIDEActive

Quantity: 240 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

AMMONIO METHACRYLATE COPOLYMER TYPE AInactive

Code: 8GQS4E66YY

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10370-830

Application NumberANDA074984

Product Classification

Marketing Category

C73584

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 21, 2023

FDA Product Classification

INGREDIENTS (18)

DILTIAZEM HYDROCHLORIDEActive

Quantity: 180 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

AMMONIO METHACRYLATE COPOLYMER TYPE AInactive

Code: 8GQS4E66YY

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

Diltiazem Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10370-832

Application NumberANDA074984

Product Classification

Marketing Category

C73584

Generic Name

Diltiazem Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 21, 2023

FDA Product Classification

INGREDIENTS (17)

DILTIAZEM HYDROCHLORIDEActive

Quantity: 300 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

AMMONIO METHACRYLATE COPOLYMER TYPE AInactive

Code: 8GQS4E66YY

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

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Diltiazem Hydrochloride

Products 4

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Diltiazem Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

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