Diltiazem Hydrochloride

These highlights do not include all the information needed to use DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively.See full prescribing information for DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS.DILTIAZEM HYDROCHLORIDE extended-release tablets, for oral useInitial U.S. Approval: 1982

Approved

Approval ID

73b3607a-99d0-44d8-92ef-0074684c9d7d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 1, 2019

Manufacturers

FDA

Oceanside Pharmaceuticals

DUNS: 832011691

Products 6

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

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68682-707

Application NumberNDA021392

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride Extended-Release Tablets

Product Specifications

Route of AdministrationORAL

Effective DateMay 1, 2019

FDA Product Classification

INGREDIENTS (16)

Diltiazem HydrochlorideActive

Quantity: 300 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

carnauba waxInactive

Code: R12CBM0EIZ

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)Inactive

Code: P2OM2Q86BI

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

microcrystalline waxInactive

Code: XOF597Q3KY

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

polydextroseInactive

Code: VH2XOU12IE

Classification: IACT

sucrose stearateInactive

Code: 274KW0O50M

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68682-709

Application NumberNDA021392

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride Extended-Release Tablets

Product Specifications

Route of AdministrationORAL

Effective DateMay 1, 2019

FDA Product Classification

INGREDIENTS (16)

carnauba waxInactive

Code: R12CBM0EIZ

Classification: IACT

ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)Inactive

Code: P2OM2Q86BI

Classification: IACT

Diltiazem HydrochlorideActive

Quantity: 420 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

polydextroseInactive

Code: VH2XOU12IE

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

microcrystalline waxInactive

Code: XOF597Q3KY

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

sucrose stearateInactive

Code: 274KW0O50M

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68682-704

Application NumberNDA021392

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride Extended-Release Tablets

Product Specifications

Route of AdministrationORAL

Effective DateMay 1, 2019

FDA Product Classification

INGREDIENTS (16)

DILTIAZEM HYDROCHLORIDEActive

Quantity: 120 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

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

Code: P2OM2Q86BI

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IE

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SUCROSE STEARATEInactive

Code: 274KW0O50M

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68682-708

Application NumberNDA021392

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride Extended-Release Tablets

Product Specifications

Route of AdministrationORAL

Effective DateMay 1, 2019

FDA Product Classification

INGREDIENTS (16)

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Diltiazem HydrochlorideActive

Quantity: 360 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

carnauba waxInactive

Code: R12CBM0EIZ

Classification: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

microcrystalline waxInactive

Code: XOF597Q3KY

Classification: IACT

ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)Inactive

Code: P2OM2Q86BI

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

polydextroseInactive

Code: VH2XOU12IE

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

sucrose stearateInactive

Code: 274KW0O50M

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68682-705

Application NumberNDA021392

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride Extended-Release Tablets

Product Specifications

Route of AdministrationORAL

Effective DateMay 1, 2019

FDA Product Classification

INGREDIENTS (16)

Diltiazem HydrochlorideActive

Quantity: 180 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

carnauba waxInactive

Code: R12CBM0EIZ

Classification: IACT

ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)Inactive

Code: P2OM2Q86BI

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

microcrystalline waxInactive

Code: XOF597Q3KY

Classification: IACT

polydextroseInactive

Code: VH2XOU12IE

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

sucrose stearateInactive

Code: 274KW0O50M

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68682-706

Application NumberNDA021392

Product Classification

Marketing Category

C73605

Generic Name

Diltiazem Hydrochloride Extended-Release Tablets

Product Specifications

Route of AdministrationORAL

Effective DateMay 1, 2019

FDA Product Classification

INGREDIENTS (16)

Diltiazem HydrochlorideActive

Quantity: 240 mg in 1 1

Code: OLH94387TE

Classification: ACTIB

carnauba waxInactive

Code: R12CBM0EIZ

Classification: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)Inactive

Code: P2OM2Q86BI

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

microcrystalline waxInactive

Code: XOF597Q3KY

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

polydextroseInactive

Code: VH2XOU12IE

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

sucrose stearateInactive

Code: 274KW0O50M

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

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Diltiazem Hydrochloride

Products 6

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Diltiazem Hydrochloride Extended-Release Tablets

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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