SULAR
Sular (nisoldipine)
Approved
Approval ID
e3780ba1-46ef-410c-b2fc-f1ffbfb598f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nisoldipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5993
Application NumberNDA020356
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2012
FDA Product Classification
INGREDIENTS (15)
NISOLDIPINEActive
Quantity: 25.5 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT