Nisoldipine
Approved
Approval ID
bab6e4c1-6ebd-4dbd-af90-12486f4f4ea6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 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 Code54868-5931
Application NumberANDA079051
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2012
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
NISOLDIPINEActive
Quantity: 40 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT