NIACIN
Niacin Tablets, USP 500 mg
Approved
Approval ID
04fb6cd5-3c21-433e-a053-623b73218bd6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
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 Code71741-047
Application NumberANDA040378
Product Classification
M
Marketing Category
C73584
G
Generic Name
NIACIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2024
FDA Product Classification
INGREDIENTS (5)
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
NIACINActive
Quantity: 500 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
HYDROGENATED SOYBEAN OILInactive
Code: A2M91M918C
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT