Diltiazem HCl CD
Diltiazem Hydrochloride CD Extended-Release Capsules
Approved
Approval ID
5e39be50-ea17-4077-a2dc-668267049f6a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2020
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
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 Code68682-521
Application NumberNDA020062
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diltiazem Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2020
FDA Product Classification
INGREDIENTS (13)
Diltiazem HydrochlorideActive
Quantity: 360 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
FD&C Blue no. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYL ACRYLATEInactive
Code: 71E6178C9T
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT