What is NDC 60760-580?

60760-580 is the product NDC for Simvastatin, Simvastatin 80 mg/1 tablet, film coated, listed with the FDA by St. Mary's Medical Park Pharmacy. It has 1 package NDC, shown above in 10- and 11-digit form.

St. Mary's Medical Park Pharmacy, NDC labeler code 60760. 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 60760-580 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60760-580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60760-0580Add 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
60760-580-30	60760058030	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-580-30)Marketed from Apr 13, 2023

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 — 80 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: St. Mary's Medical Park PharmacyNDC labeler code 60760
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078103
Marketing start: Apr 13, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 60760-580_5338a811-929e-43c3-e063-6294a90a68dbSPL ID 5338a811-929e-43c3-e063-6294a90a68dbSPL set ID f94e5e28-f0b1-700a-e053-6394a90adb7bRxCUI 200345UNII 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

N460760058030 followed by a unit qualifier and the quantity

Package 60760-0580-30. 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 Jun 1, 2026.

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 60760-580

What is NDC 60760-580?: 60760-580 is the product NDC for Simvastatin, Simvastatin 80 mg/1 tablet, film coated, listed with the FDA by St. Mary's Medical Park Pharmacy. 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?: St. Mary's Medical Park Pharmacy, NDC labeler code 60760. 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 80 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5788
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4331
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-464
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-465
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-478
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-479
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-482
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-579
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 20 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-585
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-459
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-168
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-421
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	QPharma, Inc	42708-169
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-427
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0954
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-304
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-316
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-320

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