Nicotinamide
NICOTINAMIDE
Approved
Approval ID
05813526-41d0-4451-8543-f4288ba7eb95
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Acella Pharmaceuticals, LLC
DUNS: 825380939
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nicotinamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42192-374
Product Classification
G
Generic Name
Nicotinamide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (15)
NIACINAMIDEActive
Quantity: 750 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
ZINCActive
Quantity: 27 mg in 1 1
Code: J41CSQ7QDS
Classification: ACTIB
FOLIC ACIDActive
Quantity: 850 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
COPPERActive
Quantity: 2 mg in 1 1
Code: 789U1901C5
Classification: ACTIB
CHROMIUMActive
Quantity: 100 ug in 1 1
Code: 0R0008Q3JB
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SELENIUMActive
Quantity: 50 ug in 1 1
Code: H6241UJ22B
Classification: ACTIB
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT