Nisoldipine
Nisoldipine
Approved
Approval ID
2abc5435-b2ca-4e08-89bc-ab7526781819
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2009
Manufacturers
FDA
United Research Laboratories, Inc.
DUNS: 002811818
Products 4
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 Code0677-1981
Application NumberNDA020356
Product Classification
M
Marketing Category
C73605
G
Generic Name
Nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2009
FDA Product Classification
INGREDIENTS (14)
methacrylic acid - methyl methacrylate copolymer (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
NisoldipineActive
Quantity: 34 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
glyceryl behenateInactive
Code: R8WTH25YS2
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
Nisoldipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0677-1978
Application NumberNDA020356
Product Classification
M
Marketing Category
C73605
G
Generic Name
Nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2009
FDA Product Classification
INGREDIENTS (14)
NisoldipineActive
Quantity: 8.5 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
glyceryl behenateInactive
Code: R8WTH25YS2
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
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
Nisoldipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0677-1980
Application NumberNDA020356
Product Classification
M
Marketing Category
C73605
G
Generic Name
Nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2009
FDA Product Classification
INGREDIENTS (14)
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
NisoldipineActive
Quantity: 25.5 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
glyceryl behenateInactive
Code: R8WTH25YS2
Classification: IACT
methacrylic acid - methyl methacrylate copolymer (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
Nisoldipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0677-1979
Application NumberNDA020356
Product Classification
M
Marketing Category
C73605
G
Generic Name
Nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2009
FDA Product Classification
INGREDIENTS (15)
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
NisoldipineActive
Quantity: 17 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
glyceryl behenateInactive
Code: R8WTH25YS2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
methacrylic acid - methyl methacrylate copolymer (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
FD&C yellow no. 5Inactive
Code: I753WB2F1M
Classification: IACT