Prescription drug · ANDA

Simvastatin NDC 68180-464

Simvastatin 40 mg/1 · Tablet, Film coated · Oral · Lupin Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68180-464Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0464Add 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
68180-464-03681800464031000 TABLET, FILM COATED in 1 BOTTLE (68180-464-03)Marketed from Feb 19, 2016
68180-464-066818004640630 TABLET, FILM COATED in 1 BOTTLE (68180-464-06)Marketed from Jul 29, 2016
68180-464-096818004640990 TABLET, FILM COATED in 1 BOTTLE (68180-464-09)Marketed from Apr 6, 2016

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 — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078103
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 68180-464_b78d4e8a-2261-43c6-9321-ac2539bdfd2fSPL ID b78d4e8a-2261-43c6-9321-ac2539bdfd2fSPL set ID 3e48217f-8175-4e9b-9fd0-909be4bbba95RxCUI 198211, 200345, 312961, 312962, 314231UNII AGG2FN16EVUPC 0368180478034, 0368180464037, 0368180479031, 0368180465034
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

N468180046403 followed by a unit qualifier and the quantity

Package 68180-0464-03. 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)

Simvastatin tablets USP are 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): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-464

What is NDC 68180-464?
68180-464 is the product NDC for Simvastatin, Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 3 package NDCs, 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?
Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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?
155 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 20 mg/1Tablet, Film coatedOralCoupler LLC67046-062667046-0626-03
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralCoupler LLC67046-062867046-0628-03
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralCoupler LLC67046-054267046-0542-03
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30772865-0307-0172865-0307-1072865-0307-30+2 more
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 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 20 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-37569367-0375-0969367-0375-10
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-37469367-0374-0969367-0374-10

All 156 Simvastatin NDCs

Other NDCs under ANDA 078103

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

FDA NDC Directory listings under ANDA 078103
ProductStrengthForm · routeLabelerProduct NDC
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-478
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-479
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6236
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-387
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9717
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-798
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-8406
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5788
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-809
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-966
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6306
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6307
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-579
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-580
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4331
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-465
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-585
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralQPharma, Inc.42708-168
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralQPharma, Inc42708-169
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-7992

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Simvastatin NDC 68180-464 | National Drug Code | Med-Code