Regulatory PathRegulatory requirements compared

Active substance

Nicotinic acid

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
NIACOR500MGtablet · oralAVONDALE PHARMSPrescription3 May 2000
NIACIN1GMtablet, extended release · oralBARRPrescription14 Apr 2005
NIACIN500MG; 750MGtablet, extended release · oralBARRPrescription26 Apr 2005
NIACIN1GMtablet, extended release · oralCHARTWELL RXPrescription20 Mar 2014
NIACIN500MGtablet, extended release · oralCHARTWELL RXPrescription20 Mar 2014
NIACIN750MGtablet, extended release · oralCHARTWELL RXPrescription20 Mar 2014
NIACIN500MG; 1GMtablet, extended release · oralSUN PHARMPrescription23 Apr 2014
NIACIN750MGtablet, extended release · oralSUN PHARMPrescription23 Apr 2014
NIACIN500MG; 1GMtablet, extended release · oralAMNEAL PHARMSPrescription24 Jul 2015
NIACIN750MGtablet, extended release · oralAMNEAL PHARMSPrescription11 Dec 2015
NIACIN500MG; 1GMtablet, extended release · oralQUAGENPrescription16 Jun 2017
NIACIN500MG; 750MG; 1GMtablet, extended release · oralAUROBINDO PHARMA LTDPrescription1 Feb 2018
NIACIN500MG; 1GMtablet, extended release · oralMACLEODS PHARMSPrescription3 Mar 2022
NIACIN500MG; 750MG; 1GMtablet, extended release · oralADAPTISPrescription25 Aug 2023
NIACIN500MG; 750MG; 1GMtablet, extended release · oralMPP PHARMAPrescription25 Jul 2025
WAMPOCAP500MGcapsule · oralMEDPOINTE PHARM HLCDiscontinued24 Jul 1957
NIACIN500MGtablet · oralIVAX SUB TEVA PHARMSDiscontinued15 Sep 1972
NIACIN500MGtablet · oralWATSON LABSDiscontinued4 Jan 1973
NIACIN500MGtablet · oralMK LABSDiscontinued1 Aug 1973
NIACIN500MGtablet · oralWATSON LABSDiscontinued10 Oct 1973
NICOLAR500MGtablet · oralSANOFI AVENTIS USDiscontinued26 Nov 1973
NIACIN500MGtablet · oralHIKMADiscontinued7 Jan 1974
NIACIN500MGtablet · oralWOCKHARDTDiscontinued28 Apr 1992
NIASPAN375MG; 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, extended release · oralABBVIEDiscontinued28 Jul 1997
NIASPAN TITRATION STARTER PACK375MG;500MG;750MGtablet, extended release · oralABBVIEDiscontinued28 Jul 1997

12 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACNIACIN ER 1,000 MG TABLET$0.32626per EA23 Sep 2026
US NADACNIACIN ER 500 MG TABLET$0.19288per EA23 Sep 2026
US NADACNIACIN ER 750 MG TABLET$0.28483per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for nicotinic acid →

Combinations containing Nicotinic acid

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.