Isradipine
Isradipine Capsules, USP Rx only
Approved
Approval ID
bf3425e0-428d-4bdb-ac9a-3b9d483df83a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isradipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16252-539
Application NumberANDA077317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isradipine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (13)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ISRADIPINEActive
Quantity: 2.5 mg in 1 1
Code: YO1UK1S598
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Isradipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16252-540
Application NumberANDA077317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isradipine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (12)
ISRADIPINEActive
Quantity: 5 mg in 1 1
Code: YO1UK1S598
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT