NDC codes

FDA NDC Directory
Product NDC (as listed)42708-148Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42708-0148Add 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
42708-148-30427080148304270801483030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-148-30)Marketed from Jul 30, 2021 · Sample package

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)
simvastatin
Generic name (nonproprietary)
simvastatin
Active ingredients
Simvastatin — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
QPharma, Inc.NDC labeler code 42708
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078155
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 42708-148_459be997-294f-a7cf-e063-6394a90ad491SPL ID 459be997-294f-a7cf-e063-6394a90ad491SPL set ID c80b823c-b30f-0a9d-e053-2995a90a31e9RxCUI 312961UNII AGG2FN16EV
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

N442708014830 followed by a unit qualifier and the quantity

Package 42708-0148-30. 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)

1. INDICATIONS AND USAGE Simvastatin tablet is indicated: • To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42708-148

What is NDC 42708-148?
42708-148 is the product NDC for simvastatin, Simvastatin 20 mg/1 tablet, film coated, listed with the FDA by QPharma, 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?
QPharma, Inc., NDC labeler code 42708. 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 078155

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

FDA NDC Directory listings under ANDA 078155
ProductStrengthForm · routeLabelerProduct NDC
simvastatinSimvastatin 10 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-004
simvastatinSimvastatin 20 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-005
simvastatinSimvastatin 40 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-006
simvastatinSimvastatin 80 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-007
simvastatinSimvastatin 5 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-156
simvastatinSimvastatin 40 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-726
simvastatinSimvastatin 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-727
simvastatinSimvastatin 80 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-733
simvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4897
simvastatinSimvastatin 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-598
simvastatinSimvastatin 40 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-643
simvastatinSimvastatin 20 mg/1Tablet, Film coatedOralProficient Rx LP63187-075
simvastatinSimvastatin 10 mg/1Tablet, Film coatedOralProficient Rx LP63187-191
simvastatinSimvastatin 40 mg/1Tablet, Film coatedOralProficient Rx LP63187-449
simvastatinSimvastatin 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-3385
simvastatinSimvastatin 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-3392
simvastatinSimvastatin 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-3393
simvastatinSimvastatin 80 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-3408
simvastatinSimvastatin 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-7421
simvastatinSimvastatin 40 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-1646

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