Diltiazem Hydrochloride
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
Approved
Approval ID
6e01e824-07b5-4a88-a31f-b5d673c51701
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2011
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-6126
Application NumberANDA074984
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diltiazem Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 3, 2012
FDA Product Classification
INGREDIENTS (16)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
DILTIAZEM HYDROCHLORIDEActive
Quantity: 240 mg in 1 1
Code: OLH94387TE
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
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
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT