What is NDC 47335-614?

47335-614 is the product NDC for Niacin, Niacin 750 mg/1 tablet, film coated, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 47335-614 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-614Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0614Add 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
47335-614-18	47335061418	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-614-18)Marketed from Jun 27, 2014
47335-614-81	47335061481	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-614-81)Marketed from Jun 27, 2014
47335-614-83	47335061483	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-614-83)Marketed from Jun 27, 2014
47335-614-88	47335061488	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-614-88)Marketed from Jun 27, 2014

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 — 750 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201273
Marketing start: Jun 27, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Nicotinic Acids (Chemical structure)
Identifiers: Product ID 47335-614_bc18daa3-5321-43bd-9d00-dabd9adac571SPL ID bc18daa3-5321-43bd-9d00-dabd9adac571SPL set ID 8e290f96-e8c6-47fd-863f-1c9480f28d9bRxCUI 1098134, 1098141, 1098143UNII 2679MF687AUPC 0347335613810, 0347335614817, 0347335539813
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

N447335061418 followed by a unit qualifier and the quantity

Package 47335-0614-18. 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 Nov 24, 2023.

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. Niacin extended-release tablets, USP 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 the risk of recur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-614

What is NDC 47335-614?: 47335-614 is the product NDC for Niacin, Niacin 750 mg/1 tablet, film coated, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 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?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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