Prescription drug · ANDA
Niacin NDC 62135-497
Niacin 500 mg/1 · Tablet, Extended release · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-497-90 | 6213504979062135049790 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-497-90)Marketed from Mar 8, 2023 |
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
- Chartwell RX, LLCNDC labeler code 62135
- 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 62135-497_456edffe-25de-6095-e063-6294a90a7d57SPL ID 456edffe-25de-6095-e063-6294a90a7d57SPL set ID 568c3a99-b6e8-48b4-bb68-867bbcefa027RxCUI 1098134, 1098141UNII 2679MF687AUPC 0362135497903, 0362135498900
- 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
N462135049790followed by a unit qualifier and the quantityPackage 62135-0497-90. 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 62135-497
- What is NDC 62135-497?
- 62135-497 is the product NDC for Niacin, Niacin 500 mg/1 tablet, extended release, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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 1000 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-498 |
| Niacin | Niacin 500 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 62175-320 |
| 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 |