NDC codes

FDA NDC Directory
Product NDC (as listed)68001-316Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0316Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68001-316-0068001031600100 TABLET in 1 BOTTLE (68001-316-00)Marketed from Feb 7, 2017
68001-316-08680010316081000 TABLET in 1 BOTTLE (68001-316-08)Marketed from Feb 7, 2017

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 — 40 mg/1
Dosage form
Tablet
Route
Oral
Labeler
BluePoint LaboratoriesNDC labeler code 68001
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 68001-316_52cf32e6-c51f-6fa2-e063-6394a90adb97SPL ID 52cf32e6-c51f-6fa2-e063-6394a90adb97SPL set ID 7b86160d-74a9-4774-b5b3-5641e686991fRxCUI 197903, 197904, 197905UNII 9LHU78OQFDUPC 0368001316002, 0368001314008, 0368001315005
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

N468001031600 followed by a unit qualifier and the quantity

Package 68001-0316-00. 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.

Full label on DailyMed (opens in a new tab)

About NDC 68001-316

What is NDC 68001-316?
68001-316 is the product NDC for Lovastatin, Lovastatin 40 mg/1 tablet, listed with the FDA by BluePoint Laboratories. It has 2 package NDCs, 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?
BluePoint Laboratories, NDC labeler code 68001. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lovastatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LovastatinLovastatin 40 mg/1TabletOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-14383209-0143-30
LovastatinLovastatin 20 mg/1TabletOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-46883209-0468-30
LovastatinLovastatin 10 mg/1TabletOralNorthwind Health Company, LLC51655-87351655-0873-52
LovastatinLovastatin 20 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-832668788-8326-0168788-8326-0368788-8326-06+1 more
LovastatinLovastatin 40 mg/1TabletOralNorthwind Health Company, LLC51655-46951655-0469-2651655-0469-52
LovastatinLovastatin 40 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-823268788-8232-03
LovastatinLovastatin 40 mg/1TabletOralREMEDYREPACK INC.70518-306470518-3064-0070518-3064-01
LovastatinLovastatin 10 mg/1TabletOralNorthwind Health Company, LLC51655-68651655-0686-52
LovastatinLovastatin 20 mg/1TabletOralNorthwind Health Company, LLC51655-55851655-0558-2651655-0558-52
LovastatinLovastatin 40 mg/1TabletOralREMEDYREPACK INC.70518-242570518-2425-01

All 72 Lovastatin NDCs

Other NDCs under ANDA 078296

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078296
ProductStrengthForm · routeLabelerProduct NDC
LovastatinLovastatin 20 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8151
LovastatinLovastatin 40 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8152
LovastatinLovastatin 20 mg/1TabletOralA-S Medication Solutions50090-0759
LovastatinLovastatin 40 mg/1TabletOralA-S Medication Solutions50090-0762
LovastatinLovastatin 10 mg/1TabletOralA-S Medication Solutions50090-3396
LovastatinLovastatin 40 mg/1TabletOralNorthwind Health Company, LLC51655-469
LovastatinLovastatin 20 mg/1TabletOralNorthwind Health Company, LLC51655-558
LovastatinLovastatin 10 mg/1TabletOralNorthwind Health Company, LLC51655-873
LovastatinLovastatin 40 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.55289-692
LovastatinLovastatin 20 mg/1TabletOralProficient Rx LP63187-765
LovastatinLovastatin 10 mg/1TabletOralProficient Rx LP63187-814
LovastatinLovastatin 10 mg/1TabletOralBluePoint Laboratories68001-314
LovastatinLovastatin 20 mg/1TabletOralBluePoint Laboratories68001-315
LovastatinLovastatin 20 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3261
LovastatinLovastatin 20 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3615
LovastatinLovastatin 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3622
LovastatinLovastatin 10 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-467
LovastatinLovastatin 20 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-468
LovastatinLovastatin 40 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-469
LovastatinLovastatin 20 mg/1TabletOralLegacy Pharmaceutical Packaging, LLC68645-566

Showing 20 of 28.

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