What is NDC 50268-584?

50268-584 is the product NDC for Niacin, Niacin 500 mg/1 tablet, extended release, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Niacin?

22 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Niacin NDC 50268-584 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-584Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0584Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50268-584-13	50268058413	30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-584-13) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-584-11)Marketed from Sep 14, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Niacin
Generic name (nonproprietary): niacin
Active ingredients: Niacin — 500 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203578
Marketing start: Sep 14, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Nicotinic Acids (Chemical structure)
Identifiers: Product ID 50268-584_4ba8c8c4-810e-b1f2-e063-6394a90a2d32SPL ID 4ba8c8c4-810e-b1f2-e063-6394a90a2d32SPL set ID dd60fe81-3d54-4a29-9502-601be89c575eRxCUI 1098134, 1098141UNII 2679MF687A
Pharmacologic class: Nicotinic Acid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450268058413 followed by a unit qualifier and the quantity

Package 50268-0584-13. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 25, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is 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. Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-584

What is NDC 50268-584?: 50268-584 is the product NDC for Niacin, Niacin 500 mg/1 tablet, extended release, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Niacin.
What is the active ingredient?: Niacin.
Who is the labeler?: AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Niacin?: 22 other product NDCs are listed under this name. See all Niacin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Niacin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Niacin	Niacin 500 mg/1	Tablet, Extended releaseOral	QUAGEN PHARMACEUTICALS LLC	70752-295	70752-0295-09
Niacin	Niacin 1000 mg/1	Tablet, Extended releaseOral	QUAGEN PHARMACEUTICALS LLC	70752-296	70752-0296-09
Niacin	Niacin 500 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-187	33342-0187-1033342-0187-11
Niacin	Niacin 1000 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-189	33342-0189-1033342-0189-11
Niacin	Niacin 500 mg/1	Tablet, Extended releaseOral	Aurobindo Pharma Limited	59651-018	59651-0018-0559651-0018-1859651-0018-90
Niacin	Niacin 750 mg/1	Tablet, Extended releaseOral	Aurobindo Pharma Limited	59651-019	59651-0019-0559651-0019-1859651-0019-90
Niacin	Niacin 1000 mg/1	Tablet, Extended releaseOral	Aurobindo Pharma Limited	59651-020	59651-0020-0559651-0020-1859651-0020-90
Niacin	Niacin 500 mg/1	Tablet, Extended releaseOral	Golden State Medical Supply, Inc.	51407-267	51407-0267-90
Niacin	Niacin 1000 mg/1	Tablet, Extended releaseOral	Golden State Medical Supply, Inc.	51407-268	51407-0268-90
Niacin	Niacin 500 mg/1	Tablet, Extended releaseOral	Lannett Company, Inc.	62175-320	62175-0320-4362175-0320-46

All 23 Niacin NDCs

Other NDCs under ANDA 203578

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203578
Product	Strength	Form · route	Labeler	Product NDC
Niacin	Niacin 500 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-321
Niacin	Niacin 1000 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-323