Diltiazem Hydrochloride
Diltiazem Hydrochloride Extended-Release Capsule, USP
Approved
Approval ID
fb1606ea-1cff-46fd-b8e5-8135da76436c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 2021
Manufacturers
FDA
GLENMARK PHARMACEUTICALS INC., USA
DUNS: 130597813
Products 3
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 Code68462-562
Application NumberANDA212317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diltiazem Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2021
FDA Product Classification
INGREDIENTS (19)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43C
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Diltiazem Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-850
Application NumberANDA212317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diltiazem Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2021
FDA Product Classification
INGREDIENTS (19)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43C
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Diltiazem Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-851
Application NumberANDA212317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diltiazem Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2021
FDA Product Classification
INGREDIENTS (20)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 90 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43C
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT