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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-182
Application NumberANDA217377
Product Classification
M
Marketing Category
C73584
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-181
Application NumberANDA217377
Product Classification
M
Marketing Category
C73584
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-183
Application NumberANDA217377
Product Classification
M
Marketing Category
C73584
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
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