Diltiazem Hydrochloride
Diltiazem Hydrochloride Tablets
Approved
Approval ID
c0e06da3-3d94-12a8-e053-2a95a90a6835
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2023
Manufacturers
FDA
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
DUNS: 080355546
Products 1
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 Code70934-854
Application NumberNDA018602
Product Classification
M
Marketing Category
C73605
G
Generic Name
Diltiazem Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
DILTIAZEM HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT