Niaspan
These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997
Approved
Approval ID
c64d7717-8e8e-4e17-8f00-2b18f496b321
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2012
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Niacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68258-6032
Application NumberNDA020381
Product Classification
M
Marketing Category
C73594
G
Generic Name
Niacin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2011
FDA Product Classification
INGREDIENTS (9)
NIACINActive
Quantity: 500 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT