Nisoldipine tablet, film coated, extended release

Ingredients and appearance - Product information

Nisoldipine tablet, film coated, extended release- Nisoldipine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 66993-472
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nisoldipine ( UNII: 4I8HAB65SZ)( Nisoldipine - UNII: 4I8HAB65SZ ) 8.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Hypromellose phthalate (24% phthalate, 55 cst) ( UNII: 87Y6436BKR)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Glyceryl dibehenate ( UNII: R8WTH25YS2)
Povidone, unspecified ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Methacrylic acid - methyl methacrylate copolymer (1:2) ( UNII: 5KY68S2577)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Polydextrose ( UNII: VH2XOU12IE)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Ferric oxide red ( UNII: 1K09F3G675)
Carnauba wax ( UNII: R12CBM0EIZ)

Product Characteristics

Color GRAY (Oyster) Imprint Code SCI;500
Score 1 Shape ROUND
Size 7 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA AUTHORIZED GENERIC NDA020356 USA

Nisoldipine tablet, film coated, extended release- Nisoldipine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 66993-473
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nisoldipine ( UNII: 4I8HAB65SZ)( Nisoldipine - UNII: 4I8HAB65SZ ) 17 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Hypromellose phthalate (24% phthalate, 55 cst) ( UNII: 87Y6436BKR)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Glyceryl dibehenate ( UNII: R8WTH25YS2)
Povidone, unspecified ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Methacrylic acid - methyl methacrylate copolymer (1:2) ( UNII: 5KY68S2577)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Polydextrose ( UNII: VH2XOU12IE)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Ferric oxide red ( UNII: 1K09F3G675)
Carnauba wax ( UNII: R12CBM0EIZ)
Fd&c yellow no. 5 ( UNII: I753WB2F1M)

Product Characteristics

Color YELLOW (Yellow Cream) Imprint Code SCI;501
Score 1 Shape ROUND
Size 7 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA AUTHORIZED GENERIC NDA020356 USA

Nisoldipine tablet, film coated, extended release- Nisoldipine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 66993-475
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nisoldipine ( UNII: 4I8HAB65SZ)( Nisoldipine - UNII: 4I8HAB65SZ ) 34 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Hypromellose phthalate (24% phthalate, 55 cst) ( UNII: 87Y6436BKR)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Glyceryl dibehenate ( UNII: R8WTH25YS2)
Povidone, unspecified ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Methacrylic acid - methyl methacrylate copolymer (1:2) ( UNII: 5KY68S2577)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Polydextrose ( UNII: VH2XOU12IE)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Ferric oxide red ( UNII: 1K09F3G675)
Carnauba wax ( UNII: R12CBM0EIZ)

Product Characteristics

Color ORANGE (Burnt Orange) Imprint Code SCI;503
Score 1 Shape OVAL (elliptic)
Size 15 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA AUTHORIZED GENERIC NDA020356 USA

Labeler - Prasco Laboratories( 065969375)