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
bce61158-201d-458c-be0c-9bdd2d3a0bec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2023
Manufacturers
FDA
Cipla USA, Inc.
DUNS: 078719707
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 Code69097-995
Application NumberANDA216327
Product Classification
M
Marketing Category
C73584
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (11)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
diltiazem hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-993
Application NumberANDA216327
Product Classification
M
Marketing Category
C73584
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
DILTIAZEM HYDROCHLORIDEActive
Quantity: 180 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
diltiazem hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-997
Application NumberANDA216327
Product Classification
M
Marketing Category
C73584
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DILTIAZEM HYDROCHLORIDEActive
Quantity: 420 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
diltiazem hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-996
Application NumberANDA216327
Product Classification
M
Marketing Category
C73584
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DILTIAZEM HYDROCHLORIDEActive
Quantity: 360 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
diltiazem hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-992
Application NumberANDA216327
Product Classification
M
Marketing Category
C73584
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (11)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
diltiazem hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-994
Application NumberANDA216327
Product Classification
M
Marketing Category
C73584
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (11)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 240 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT