Prescription drug · ANDA
Lovastatin NDC 0615-8152
Lovastatin 40 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8152-39 | 00615815239 | 30 TABLET in 1 BLISTER PACK (0615-8152-39)Marketed from Jul 10, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- 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 0615-8152_5b45e9ad-8c7f-43d0-8989-469795156f90SPL ID 5b45e9ad-8c7f-43d0-8989-469795156f90SPL set ID 3af47e72-082d-42ad-bde0-294f8101b45cRxCUI 197904, 197905UNII 9LHU78OQFD
- 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
N400615815239followed by a unit qualifier and the quantityPackage 00615-8152-39. 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 0615-8152
- What is NDC 0615-8152?
- 0615-8152 is the product NDC for Lovastatin, Lovastatin 40 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. 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?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 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 |
| Lovastatin | Lovastatin 20 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-566 |
Showing 20 of 28.