Niacin
These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS. NIACIN extended-release tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 25, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 2
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 Code33342-189
Application NumberANDA204934
Product Classification
M
Marketing Category
C73584
G
Generic Name
Niacin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (9)
NIACINActive
Quantity: 1000 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Niacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-187
Application NumberANDA204934
Product Classification
M
Marketing Category
C73584
G
Generic Name
Niacin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (9)
NIACINActive
Quantity: 500 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT