Nicardipine Hydrochloride
Nicardipine Hydrochloride Capsules, 20 mg and 30 mgRx only
Approved
Approval ID
c6fd802a-136a-455d-9bff-9a28583ffa6d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 3, 2023
Manufacturers
FDA
SQUARE PHARMACEUTICALS LIMITED
DUNS: 731487153
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nicardipine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76483-087
Application NumberANDA217555
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicardipine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (9)
NICARDIPINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: K5BC5011K3
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Nicardipine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76483-088
Application NumberANDA217555
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicardipine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (9)
NICARDIPINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: K5BC5011K3
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT