What is NDC 65162-321?

65162-321 is the product NDC for Niacin, Niacin 500 mg/1 tablet, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 65162-321 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-321Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0321Add 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
65162-321-03	65162032103	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-03)Marketed from Jul 27, 2015
65162-321-09	65162032109	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-09)Marketed from Jul 27, 2015
65162-321-50	65162032150	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-50)Marketed from Jul 27, 2015

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: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203578
Marketing start: Jul 27, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Nicotinic Acids (Chemical structure)
Identifiers: Product ID 65162-321_7d50546f-6768-4b4f-969b-51f935c71cdbSPL ID 7d50546f-6768-4b4f-969b-51f935c71cdb
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

N465162032103 followed by a unit qualifier and the quantity

Package 65162-0321-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 65162-321

What is NDC 65162-321?: 65162-321 is the product NDC for Niacin, Niacin 500 mg/1 tablet, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 3 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?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 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	Aurobindo Pharma Limited	59651-018	59651-0018-0559651-0018-1859651-0018-90
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

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 1000 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-323
Niacin	Niacin 500 mg/1	Tablet, Extended releaseOral	AvPAK	50268-584