What is NDC 53401-018?

53401-018 is the product NDC for Simvastatin, Simvastatin 80 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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 53401-018 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53401-018Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53401-0018Add 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
53401-018-45	53401001845	45 TABLET, FILM COATED in 1 BOTTLE (53401-018-45)Marketed from Jul 2, 2026

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078034
Marketing start: Dec 20, 2006
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 53401-018_55f97c28-8481-5d55-e063-6294a90a950dSPL ID 55f97c28-8481-5d55-e063-6294a90a950dSPL set ID 55f92c72-e690-85dd-e063-6394a90adb39RxCUI 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

N453401001845 followed by a unit qualifier and the quantity

Package 53401-0018-45. 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 Jul 6, 2026.

Indications (excerpt from the label)

Simvastatin tablets 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 redu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53401-018

What is NDC 53401-018?: 53401-018 is the product NDC for Simvastatin, Simvastatin 80 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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 078034

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

FDA NDC Directory listings under ANDA 078034
Product	Strength	Form · route	Labeler	Product NDC
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6459
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-113
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-448
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	53401-013
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	53401-026
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc,	70377-001
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc,	70377-002
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc,	70377-003
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc,	70377-004
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc,	70377-005
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3630
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3648
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4102
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1891
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1905
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1906
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-609
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-610
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-611
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-615

Showing 20 of 27.