NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2559Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2559Add 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
68071-2559-3680712559036807125590330 TABLET, FILM COATED in 1 BOTTLE (68071-2559-3)Marketed from Oct 29, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Simvastatin
Generic name (nonproprietary)
simvastatin
Active ingredients
Simvastatin — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077691
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 68071-2559_2dcc5a08-ac32-cd35-e063-6294a90a8524SPL ID 2dcc5a08-ac32-cd35-e063-6294a90a8524SPL set ID cf859977-2d84-0fcb-e053-2a95a90a6269RxCUI 198211UNII AGG2FN16EVUPC 0368071255935
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

N468071255903 followed by a unit qualifier and the quantity

Package 68071-2559-03. 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 hypercholesterolemia. Drug 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. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet. Simvastatin tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce the risk of total mortality by reducing CHD deaths and…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-2559

What is NDC 68071-2559?
68071-2559 is the product NDC for Simvastatin, Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Simvastatin.
What is the active ingredient?
Simvastatin.
Who is the labeler?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Simvastatin?
156 other product NDCs are listed under this name. See all Simvastatin 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 Simvastatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralCoupler LLC67046-062867046-0628-03
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralCoupler LLC67046-062667046-0626-03
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralCoupler LLC67046-054267046-0542-03
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30572865-0305-0172865-0305-1072865-0305-30+1 more
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30672865-0306-0172865-0306-1072865-0306-30+1 more
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30772865-0307-0172865-0307-1072865-0307-30+2 more
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30872865-0308-0172865-0308-1072865-0308-30+2 more
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30972865-0309-0172865-0309-0572865-0309-10+3 more
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-37669367-0376-0969367-0376-10
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-37469367-0374-0969367-0374-10

All 157 Simvastatin NDCs

Other NDCs under ANDA 077691

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

FDA NDC Directory listings under ANDA 077691
ProductStrengthForm · routeLabelerProduct NDC
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2262
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-780
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6421
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6424
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6425
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7088
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4801
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7776
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7782
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7777
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7780
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7781
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7783
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5019
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6922
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-683
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-681
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-682
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-684
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-685

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