What is NDC 68071-4331?

68071-4331 is the product NDC for Simvastatin, Simvastatin 10 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.

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?

155 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Simvastatin NDC 68071-4331 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-4331Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-4331Add 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 NDC	11-digit (billing)	Package	Copy
68071-4331-9	68071433109	90 TABLET, FILM COATED in 1 BOTTLE (68071-4331-9)Marketed from Mar 12, 2018

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 — 10 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 078103
Marketing start: Jun 12, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 68071-4331_2d3ff27f-de05-c79c-e063-6294a90a05c3SPL ID 2d3ff27f-de05-c79c-e063-6294a90a05c3SPL set ID 673dfc44-d407-f9ac-e053-2a91aa0a4702RxCUI 314231UNII AGG2FN16EVUPC 0368071433197
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

N468071433109 followed by a unit qualifier and the quantity

Package 68071-4331-09. 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 Feb 3, 2025.

Indications (excerpt from the label)

Simvastatin tablets USP 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 reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. ( 1.1 ) Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. ( 1.2 ) Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. ( 1.2 ) Reduce total-C and LDL-C in adult patients with homo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-4331

What is NDC 68071-4331?: 68071-4331 is the product NDC for Simvastatin, Simvastatin 10 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?: 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0626	67046-0626-03
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0628	67046-0628-03
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0542	67046-0542-03
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-305	72865-0305-0172865-0305-1072865-0305-30+1 more
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-306	72865-0306-0172865-0306-1072865-0306-30+1 more
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-307	72865-0307-0172865-0307-1072865-0307-30+2 more
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-308	72865-0308-0172865-0308-1072865-0308-30+2 more
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-309	72865-0309-0172865-0309-0572865-0309-10+3 more
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-374	69367-0374-0969367-0374-10
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-375	69367-0375-0969367-0375-10

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
Product	Strength	Form · route	Labeler	Product NDC
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7992
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7993
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8056
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-168
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	QPharma, Inc	42708-169
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4736
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4901
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5788
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6236
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6306
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6307
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6920
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-387
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-459
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-4782
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-210
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-579
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-580
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-585
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0542

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