Prescription drug · ANDA
Lovastatin NDC 68645-566
Lovastatin 20 mg/1 · Tablet · Oral · Legacy Pharmaceutical Packaging, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68645-566-90 | 68645056690 | 90 TABLET in 1 BOTTLE (68645-566-90)Marketed from Nov 1, 2007 |
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)
- Lovastatin
- Generic name (nonproprietary)
- lovastatin
- Active ingredients
- Lovastatin — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Legacy Pharmaceutical Packaging, LLCNDC labeler code 68645
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078296
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68645-566_4cc241a1-d876-0439-e063-6394a90a2733SPL ID 4cc241a1-d876-0439-e063-6394a90a2733SPL set ID a4f02fa1-3281-46fa-bd52-323e2644b6f8RxCUI 197904, 197905UNII 9LHU78OQFDUPC 0368645566900, 0368645567907
- Pharmacologic class
- HMG-CoA Reductase Inhibitor
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
N468645056690followed by a unit qualifier and the quantityPackage 68645-0566-90. 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)
INDICATIONS AND USAGE Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicat…
Excerpt only. Read the full label for complete information.
About NDC 68645-566
- What is NDC 68645-566?
- 68645-566 is the product NDC for Lovastatin, Lovastatin 20 mg/1 tablet, listed with the FDA by Legacy Pharmaceutical Packaging, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lovastatin.
- What is the active ingredient?
- Lovastatin.
- Who is the labeler?
- Legacy Pharmaceutical Packaging, LLC, NDC labeler code 68645. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lovastatin?
- 71 other product NDCs are listed under this name. See all Lovastatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lovastatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-143 | 83209-0143-30 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-468 | 83209-0468-30 |
| Lovastatin | Lovastatin 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-873 | 51655-0873-52 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-8326 | 68788-8326-0168788-8326-0368788-8326-06+1 more |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-469 | 51655-0469-2651655-0469-52 |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-8232 | 68788-8232-03 |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3064 | 70518-3064-0070518-3064-01 |
| Lovastatin | Lovastatin 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-686 | 51655-0686-52 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-558 | 51655-0558-2651655-0558-52 |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2425 | 70518-2425-01 |
Other NDCs under ANDA 078296
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 |
|---|---|---|---|---|
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8151 |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8152 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-0759 |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-0762 |
| Lovastatin | Lovastatin 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-3396 |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-469 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-558 |
| Lovastatin | Lovastatin 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-873 |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-692 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | Proficient Rx LP | 63187-765 |
| Lovastatin | Lovastatin 10 mg/1 | TabletOral | Proficient Rx LP | 63187-814 |
| Lovastatin | Lovastatin 10 mg/1 | TabletOral | BluePoint Laboratories | 68001-314 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | BluePoint Laboratories | 68001-315 |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | BluePoint Laboratories | 68001-316 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3261 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3615 |
| Lovastatin | Lovastatin 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3622 |
| Lovastatin | Lovastatin 10 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-467 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-468 |
| Lovastatin | Lovastatin 40 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-469 |
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