Diltiazem Hydrochloride
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Approved
Approval ID
f276d9fe-a685-4d99-ad82-d4452ef4ba98
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
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
NDC Product Code24979-182
Application NumberANDA217377
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 1, 2023
Generic Namediltiazem hydrochloride
INGREDIENTS (19)
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
DILTIAZEM HYDROCHLORIDEActive
Quantity: 90 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
diltiazem hydrochloride
PRODUCT DETAILS
NDC Product Code24979-181
Application NumberANDA217377
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 1, 2023
Generic Namediltiazem hydrochloride
INGREDIENTS (18)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
diltiazem hydrochloride
PRODUCT DETAILS
NDC Product Code24979-183
Application NumberANDA217377
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 1, 2023
Generic Namediltiazem hydrochloride
INGREDIENTS (19)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT