What is NDC 0781-8017?

0781-8017 is the product NDC for Fluvastatin Sodium ER (fluvastatin sodium), Fluvastatin sodium 80 mg/1 tablet, extended release, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Fluvastatin Sodium ER (Fluvastatin sodium).

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fluvastatin Sodium ER?

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.

Fluvastatin Sodium ER NDC 0781-8017

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-8017Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-8017Add 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
0781-8017-01	0078180170100781801701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-01)Marketed from May 2, 2018
0781-8017-31	0078180173100781801731	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-31)Marketed from May 2, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Fluvastatin Sodium ERSuffix: ER
Generic name (nonproprietary): fluvastatin sodium
Active ingredients: Fluvastatin sodium — 80 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021192
Marketing start: Oct 16, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 0781-8017_37375ca6-3a81-4d10-9b39-9aee948e51a4SPL ID 37375ca6-3a81-4d10-9b39-9aee948e51a4SPL set ID 5ab4296c-87c2-4c64-b218-d620eef51310RxCUI 360507UNII PYF7O1FV7FUPC 0307818017313
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

N400781801701 followed by a unit qualifier and the quantity

Package 00781-8017-01. 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 31, 2024.

Indications (excerpt from the label)

Fluvastatin sodium extended-release tablets are 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. Fluvastatin sodium extended-release tablets are indicated ( 1 ): • To reduce the risk of undergoing coronary revascularization procedures and slow…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-8017

What is NDC 0781-8017?: 0781-8017 is the product NDC for Fluvastatin Sodium ER (fluvastatin sodium), Fluvastatin sodium 80 mg/1 tablet, extended release, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fluvastatin Sodium ER (Fluvastatin sodium).
What is the active ingredient?: Fluvastatin sodium.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluvastatin Sodium ER?: 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
Lescol XLfluvastatin sodium	Fluvastatin sodium 80 mg/1	Tablet, Extended releaseOral	Sandoz Inc	66758-211

Fluvastatin Sodium ER (Fluvastatin sodium) NDC 0781-8017