What is NDC 82009-015?

82009-015 is the product NDC for Simvastatin, Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. 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 82009-015 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82009-015Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82009-0015Add 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
82009-015-10	8200900151082009001510	1000 TABLET, FILM COATED in 1 BOTTLE (82009-015-10)Marketed from May 26, 2022

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: Quallent Pharmaceuticals Health LLCNDC labeler code 82009
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200895
Marketing start: May 26, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 82009-015_1de47781-9000-0fc1-e063-6294a90a8139SPL ID 1de47781-9000-0fc1-e063-6294a90a8139SPL set ID 2b4255a7-f9f5-4235-8dbb-b0f03acbd624RxCUI 198211, 200345, 312961, 312962, 314231UNII AGG2FN16EVUPC 0382009015101, 0382009013107, 0382009014104, 0382009012100
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

N482009001510 followed by a unit qualifier and the quantity

Package 82009-0015-10. 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 23, 2024.

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): 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 LDL-C-lowering therapi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82009-015

What is NDC 82009-015?: 82009-015 is the product NDC for Simvastatin, Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by Quallent Pharmaceuticals Health 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?: Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. 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 200895

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

FDA NDC Directory listings under ANDA 200895
Product	Strength	Form · route	Labeler	Product NDC
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-012
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-013
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-014
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-016
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-305
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-306
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-307
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-308
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-309
Simvastatin	Simvastatin 5 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-510
Simvastatin	Simvastatin 10 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-511
Simvastatin	Simvastatin 20 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-512
Simvastatin	Simvastatin 40 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-513
Simvastatin	Simvastatin 80 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-514