Medicine
Niacin 500 mg extended-release tablet
Niacin 500 mg extended-release tablet is a generic prescription medicine for oral use, made by 8 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Niacin
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 500 tablets, 180 tablets, 90 tablets and 14 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaAmneal PharmaceuticalsLannettAvPAKChartwell RXGolden State Medical SupplyQuagen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C04AC01 Niacin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 June 2014
- Identifiers
- RxCUI 1098134, 1098141, 1098143DailyMed set ID dd60fe81-3d54-4a29-9502-601be89c575e, 6e604319-e164-4056-ab80-b78b98c519c7, 249e27ac-e1e7-42dc-84f6-cd32fd1d9dee +4NDC 50268-584, 65162-321, 70752-295 +5Application ANDA203578, ANDA203899, ANDA209236 +1
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet, extended release in 1 bottle | 59651-018-05 | Aurobindo PharmaIndia | 1 February 2018 |
| 180 tablet, extended release in 1 bottle | 59651-018-18 | Aurobindo PharmaIndia | 1 February 2018 |
| 90 tablet, extended release in 1 bottle | 59651-018-90 | Aurobindo PharmaIndia | 1 February 2018 |
| 100 tablet, film coated, extended release in 1 bottle | 47335-539-08 | Sun Pharmaceutical IndustriesIndia | 27 June 2014 |
| 1000 tablet, film coated, extended release in 1 bottle | 47335-539-18 | Sun Pharmaceutical IndustriesIndia | 27 June 2014 |
| 90 tablet, film coated, extended release in 1 bottle | 47335-539-81 | Sun Pharmaceutical IndustriesIndia | 27 June 2014 |
| 30 tablet, film coated, extended release in 1 bottle | 47335-539-83 | Sun Pharmaceutical IndustriesIndia | 27 June 2014 |
| 100 tablet, film coated, extended release in 1 bottle | 47335-539-88 | Sun Pharmaceutical IndustriesIndia | 27 June 2014 |
| 30 tablet, extended release in 1 bottle | 65162-321-03 | Amneal Pharmaceuticals | 27 July 2015 |
| 90 tablet, extended release in 1 bottle | 65162-321-09 | Amneal Pharmaceuticals | 27 July 2015 |
| 500 tablet, extended release in 1 bottle | 65162-321-50 | Amneal Pharmaceuticals | 27 July 2015 |
| 90 tablet, extended release in 1 bottle | 62135-497-90 | Chartwell RX | 8 March 2023 |
| 1000 tablet, extended release in 1 bottle | 62175-320-43 | Lannett | 16 February 2017 |
| 90 tablet, extended release in 1 bottle | 62175-320-46 | Lannett | 16 February 2017 |
| 90 tablet, extended release in 1 bottle | 70752-295-09 | Quagen Pharmaceuticals | 6 August 2026 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, extended release in 1 blister pack | 50268-584-13 | AvPAK | 14 September 2017 |
| 90 tablet, extended release in 1 bottle | 51407-267-90 | Golden State Medical Supply | 5 July 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 July 1957 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Niacin
Clinical summary
Niacin is a nicotinic acid indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate, among other approved uses. MedsAcross supplies Niacin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about NiacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Niacin prescribing information (Amneal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Niacin 500 mg extended-release tablet for your hospital or patient?
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