Diltiazem Hydrochloride
Diltiazem Hydrochloride Extended-Release Capsules, USP Rx Only
Approved
Approval ID
0e9b4421-bc43-4a77-b49b-e3f53d1e0f01
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-2154
Application NumberANDA074984
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diltiazem Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2017
FDA Product Classification
INGREDIENTS (15)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE BInactive
Code: 161H3B14U2
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT