Prescription drug · ANDA
Niacin NDC 62175-320
Niacin 500 mg/1 · Tablet, Extended release · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62175-320-43 | 6217503204362175032043 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-320-43)Marketed from Feb 16, 2017 | |
| 62175-320-46 | 6217503204662175032046 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-320-46)Marketed from Feb 16, 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
- Lannett Company, Inc.NDC labeler code 62175
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203899
- Marketing start
- Listing expires
- Other FDA classes
- Nicotinic Acids (Chemical structure)
- Identifiers
- Product ID 62175-320_7e9530d1-a940-42e8-b754-0d4089b39db1SPL ID 7e9530d1-a940-42e8-b754-0d4089b39db1SPL set ID d7b66e13-00ed-48a9-a54a-8e474cc31d54RxCUI 1098134, 1098141UNII 2679MF687AUPC 0362175320469
- 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
N462175032043followed by a unit qualifier and the quantityPackage 62175-0320-43. 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 .
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 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. 2. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recu…
Excerpt only. Read the full label for complete information.
About NDC 62175-320
- What is NDC 62175-320?
- 62175-320 is the product NDC for Niacin, Niacin 500 mg/1 tablet, extended release, listed with the FDA by Lannett Company, Inc.. 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?
- Lannett Company, Inc., NDC labeler code 62175. 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.
Related NDCs: other Niacin products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | AvPAK | 50268-584 | 50268-0584-13 |
| 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 |
Other NDCs under ANDA 203899
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Niacin | Niacin 500 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-267 |
| Niacin | Niacin 1000 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-268 |
| Niacin | Niacin 500 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-497 |
| Niacin | Niacin 1000 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-498 |
| Niacin | Niacin 1000 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 62175-322 |
| Niacin | Niacin 500 mg/1 | Tablet, Extended releaseOral | QUAGEN PHARMACEUTICALS LLC | 70752-295 |
| Niacin | Niacin 1000 mg/1 | Tablet, Extended releaseOral | QUAGEN PHARMACEUTICALS LLC | 70752-296 |