What is NDC 66758-211?

66758-211 is the product NDC for Lescol XL (fluvastatin sodium), Fluvastatin sodium 80 mg/1 tablet, extended release, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Lescol XL (Fluvastatin sodium).

Sandoz Inc, NDC labeler code 66758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lescol XL?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lescol XL NDC 66758-211 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)66758-211Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66758-0211Add 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
66758-211-31	6675802113166758021131	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31)Marketed from Aug 2, 2024

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): Lescol XLSuffix: XL
Generic name (nonproprietary): fluvastatin sodium
Active ingredients: Fluvastatin sodium — 80 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Sandoz IncNDC labeler code 66758
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021192
Marketing start: Oct 6, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 66758-211_726ea2db-f1b0-4b73-a515-02157db88a42SPL ID 726ea2db-f1b0-4b73-a515-02157db88a42SPL set ID 726ea2db-f1b0-4b73-a515-02157db88a42RxCUI 360507, 687048UNII PYF7O1FV7F
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

N466758021131 followed by a unit qualifier and the quantity

Package 66758-0211-31. 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 Dec 13, 2023.

Indications (excerpt from the label)

LESCOL XL is indicated: • To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. • As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily. LESCOL XL is indicated ( 1 ): • To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66758-211

What is NDC 66758-211?: 66758-211 is the product NDC for Lescol XL (fluvastatin sodium), Fluvastatin sodium 80 mg/1 tablet, extended release, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lescol XL (Fluvastatin sodium).
What is the active ingredient?: Fluvastatin sodium.
Who is the labeler?: Sandoz Inc, NDC labeler code 66758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lescol XL?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 021192

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

FDA NDC Directory listings under NDA 021192
Product	Strength	Form · route	Labeler	Product NDC
Fluvastatin Sodium ERfluvastatin sodium	Fluvastatin sodium 80 mg/1	Tablet, Extended releaseOral	Sandoz Inc	0781-8017

Lescol XL (Fluvastatin sodium) NDC 66758-211