Prescription drug · ANDA
Niacin NDC 59651-019
Niacin 750 mg/1 · Tablet, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-019-05 | 59651001905 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-05)Marketed from Feb 1, 2018 | |
| 59651-019-18 | 59651001918 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-18)Marketed from Feb 1, 2018 | |
| 59651-019-90 | 59651001990 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-90)Marketed from Feb 1, 2018 |
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, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209236
- Marketing start
- Listing expires
- Other FDA classes
- Nicotinic Acids (Chemical structure)
- Identifiers
- Product ID 59651-019_8539231f-47da-402e-b05d-16c45cc3670cSPL ID 8539231f-47da-402e-b05d-16c45cc3670cSPL set ID 43233a21-3f90-4c69-bbeb-f50d5f2d35aeRxCUI 1098134, 1098141, 1098143UNII 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
N459651001905followed by a unit qualifier and the quantityPackage 59651-0019-05. 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. 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 the risk of recurrent …
Excerpt only. Read the full label for complete information.
About NDC 59651-019
- What is NDC 59651-019?
- 59651-019 is the product NDC for Niacin, Niacin 750 mg/1 tablet, extended release, listed with the FDA by Aurobindo Pharma Limited. 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 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 |
| Niacin | Niacin 500 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 62175-320 | 62175-0320-4362175-0320-46 |
Other NDCs under ANDA 209236
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 | Aurobindo Pharma Limited | 59651-018 |
| Niacin | Niacin 1000 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 59651-020 |