What is NDC 51655-459?

51655-459 is the product NDC for Simvastatin, Simvastatin 20 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Northwind Health Company, LLC, NDC labeler code 51655. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Simvastatin NDC 51655-459 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51655-459Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51655-0459Add 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
51655-459-26	5165504592651655045926	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-459-26)Marketed from Apr 17, 2023
51655-459-52	5165504595251655045952	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-459-52)Marketed from Mar 29, 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 — 20 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Northwind Health Company, LLCNDC labeler code 51655
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078103
Marketing start: Mar 29, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 51655-459_4b44dced-150a-df18-e063-6294a90a93d6SPL ID 4b44dced-150a-df18-e063-6294a90a93d6SPL set ID f86de805-e4ec-4bca-e053-6294a90a1fc3RxCUI 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

N451655045926 followed by a unit qualifier and the quantity

Package 51655-0459-26. 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 Jan 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 51655-459

What is NDC 51655-459?: 51655-459 is the product NDC for Simvastatin, Simvastatin 20 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. It has 2 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?: Northwind Health Company, LLC, NDC labeler code 51655. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0628	67046-0628-03
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0626	67046-0626-03
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 40 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-376	69367-0376-0969367-0376-10
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-374	69367-0374-0969367-0374-10

All 157 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 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 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 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4331
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-585
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-798
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-809
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 80 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9717
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-966
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0954
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8056
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0542
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4901
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0626
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0628
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-511

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