Prescription drug · ANDA
Niacor (Niacin) NDC 71740-001
Niacin 500 mg/1 · Tablet · Oral · Avondale Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71740-001-10 | 71740000110 | 100 TABLET in 1 BOTTLE (71740-001-10)Marketed from Dec 16, 2021 |
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)
- Niacor
- Generic name (nonproprietary)
- niacin
- Active ingredients
- Niacin — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Avondale Pharmaceuticals, LLCNDC labeler code 71740
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040378
- Marketing start
- Listing expires
- Other FDA classes
- Nicotinic Acids (Chemical structure)
- Identifiers
- Product ID 71740-001_800ff22d-b10c-4cc8-920f-217a4d23563dSPL ID 800ff22d-b10c-4cc8-920f-217a4d23563dSPL set ID bf287412-160b-403f-8eb4-57f29a475902RxCUI 198024, 311944UNII 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
N471740000110followed by a unit qualifier and the quantityPackage 71740-0001-10. 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)
INDICATIONS AND USAGE I. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Nicotinic acid, alone or in combination with a bile-acid binding resin, is indicated as an adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia (Types IIa and IIb) † , when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate (see also the NCEP treatment guidelines 6 ). Prior to initiating therapy with nic…
Excerpt only. Read the full label for complete information.
About NDC 71740-001
- What is NDC 71740-001?
- 71740-001 is the product NDC for Niacor (niacin), Niacin 500 mg/1 tablet, listed with the FDA by Avondale Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Niacor (Niacin).
- What is the active ingredient?
- Niacin.
- Who is the labeler?
- Avondale Pharmaceuticals, LLC, NDC labeler code 71740. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Niacor?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 040378
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 | TabletOral | Redmont Pharmaceuticals, LLC | 71741-020 |
| Niacin | Niacin 500 mg/1 | TabletOral | Emerald Therapeutics, LLC | 72919-420 |