What is NDC 33342-189?

33342-189 is the product NDC for Niacin, Niacin 1000 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 33342-189 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-189Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0189Add 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
33342-189-10	33342018910	90 TABLET in 1 BOTTLE (33342-189-10)Marketed from Mar 3, 2022
33342-189-11	33342018911	100 TABLET in 1 BOTTLE (33342-189-11)Marketed from Mar 3, 2022

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 — 1000 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204934
Marketing start: Mar 3, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Nicotinic Acids (Chemical structure)
Identifiers: Product ID 33342-189_2b583ae0-4d24-bd44-e063-6394a90a0cedSPL ID 2b583ae0-4d24-bd44-e063-6394a90a0cedSPL set ID 52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064eRxCUI 1098134, 1098141UNII 2679MF687AUPC 0333342187116, 0333342187109, 0333342189103
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

N433342018910 followed by a unit qualifier and the quantity

Package 33342-0189-10. 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 Jan 10, 2025.

Indications (excerpt from the label)

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. 1. Niacin extended-release tablet is 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. 2. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-189

What is NDC 33342-189?: 33342-189 is the product NDC for Niacin, Niacin 1000 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, 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?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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	Tablet, Extended releaseOral	Aurobindo Pharma Limited	59651-020	59651-0020-0559651-0020-1859651-0020-90
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 500 mg/1	Tablet, Extended releaseOral	AvPAK	50268-584	50268-0584-13
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	Golden State Medical Supply, Inc.	51407-267	51407-0267-90
Niacin	Niacin 1000 mg/1	Tablet, Extended releaseOral	Chartwell RX, LLC	62135-498	62135-0498-90

All 23 Niacin NDCs

Other NDCs under ANDA 204934

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

FDA NDC Directory listings under ANDA 204934
Product	Strength	Form · route	Labeler	Product NDC
Niacin	Niacin 500 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-187