Nisoldipine
{'content': {'@styleCode': 'bold'}}
Approved
Approval ID
00d506a4-74d6-4838-b008-3f9e7c017e08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2022
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
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 Code0378-2096
Application NumberANDA091001
Product Classification
M
Marketing Category
C73584
G
Generic Name
nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (17)
NISOLDIPINEActive
Quantity: 8.5 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
nisoldipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-2099
Application NumberANDA091001
Product Classification
M
Marketing Category
C73584
G
Generic Name
nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NISOLDIPINEActive
Quantity: 34 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
nisoldipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-2098
Application NumberANDA091001
Product Classification
M
Marketing Category
C73584
G
Generic Name
nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (17)
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
NISOLDIPINEActive
Quantity: 25.5 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
nisoldipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-2097
Application NumberANDA091001
Product Classification
M
Marketing Category
C73584
G
Generic Name
nisoldipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (18)
NISOLDIPINEActive
Quantity: 17 mg in 1 1
Code: 4I8HAB65SZ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT