Diltiazem Hydrochloride
DILTIAZEM HYDROCHLORIDE TABLETS USP0318031903200321Rx only
Approved
Approval ID
59e204ce-b232-4aeb-9452-a502ef37ed0b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2013
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code33261-183
Application NumberANDA074185
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diltiazem Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2013
FDA Product Classification
INGREDIENTS (10)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT