Fluvastatin
These highlights do not include all the information needed to use FLUVASTATIN CAPSULES safely and effectively. See full prescribing information for FLUVASTATIN CAPSULES. FLUVASTATIN capsules, for oral useInitial U.S. Approval: 1993
Approved
Approval ID
f5e8d1da-8911-42db-9f90-cba04b28d011
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8812
Application NumberANDA078407
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvastatin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (13)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FLUVASTATIN SODIUMActive
Quantity: 20 mg in 1 1
Code: PYF7O1FV7F
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT