What is NDC 51655-643?

51655-643 is the product NDC for simvastatin, Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. It has 1 package NDC, 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 51655-643 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51655-643Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51655-0643Add 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
51655-643-26	5165506432651655064326	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-643-26)Marketed from Oct 12, 2020

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: Northwind Health Company, LLCNDC labeler code 51655
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078155
Marketing start: Oct 12, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 51655-643_494f7700-2c27-9b91-e063-6294a90a08caSPL ID 494f7700-2c27-9b91-e063-6294a90a08caSPL set ID f32d512f-86fa-b70f-e053-2a95a90afd01RxCUI 198211UNII 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

N451655064326 followed by a unit qualifier and the quantity

Package 51655-0643-26. 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)

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 51655-643

What is NDC 51655-643?: 51655-643 is the product NDC for simvastatin, Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. 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?: 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 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
Product	Strength	Form · route	Labeler	Product NDC
simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-004
simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-005
simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-006
simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-007
simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-156
simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-148
simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-726
simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-727
simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-733
simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4897
simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-598
simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-075
simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-191
simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-449
simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-3385
simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-3392
simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-3393
simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-3408
simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-7421
simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-1646

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