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
43233a21-3f90-4c69-bbeb-f50d5f2d35ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 3
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 Code59651-020
Application NumberANDA209236
Product Classification
M
Marketing Category
C73584
G
Generic Name
Niacin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (10)
NIACINActive
Quantity: 1000 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Niacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-019
Application NumberANDA209236
Product Classification
M
Marketing Category
C73584
G
Generic Name
Niacin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NIACINActive
Quantity: 750 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
Niacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-018
Application NumberANDA209236
Product Classification
M
Marketing Category
C73584
G
Generic Name
Niacin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
NIACINActive
Quantity: 500 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT