Niacin
Niacin Tablets, USP 500 mg
Approved
Approval ID
f51f7e6d-b132-48d8-8bb1-54203472f0d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2021
Manufacturers
FDA
Redmont Pharmaceuticals, LLC
DUNS: 080843607
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 Code71741-020
Application NumberANDA040378
Product Classification
M
Marketing Category
C73584
G
Generic Name
Niacin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (5)
HYDROGENATED SOYBEAN OILInactive
Code: A2M91M918C
Classification: IACT
NiacinActive
Quantity: 500 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT