What is NDC 0527-2580?

0527-2580 is the product NDC for Fluvastatin Sodium, Fluvastatin sodium 80 mg/1 tablet, film coated, extended release, listed with the FDA by Lannett Company, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Lannett Company, Inc., NDC labeler code 0527. 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?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluvastatin Sodium NDC 0527-2580 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-2580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-2580Add 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
0527-2580-32	0052725803200527258032	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-32)Marketed from May 7, 2021
0527-2580-37	0052725803700527258037	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-37)Marketed from Mar 14, 2022

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
Generic name (nonproprietary): fluvastatin sodium
Active ingredients: Fluvastatin sodium — 80 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 0527
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209397
Marketing start: May 7, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 0527-2580_4d56c57e-1d38-e010-e063-6294a90a8c83SPL ID 4d56c57e-1d38-e010-e063-6294a90a8c83SPL set ID 3565bfd3-ef9f-456d-b4be-a294a7a0f01cRxCUI 360507UNII 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

N400527258032 followed by a unit qualifier and the quantity

Package 00527-2580-32. 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 Mar 18, 2026.

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 the pro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0527-2580

What is NDC 0527-2580?: 0527-2580 is the product NDC for Fluvastatin Sodium, Fluvastatin sodium 80 mg/1 tablet, film coated, extended release, listed with the FDA by Lannett Company, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fluvastatin Sodium.
What is the active ingredient?: Fluvastatin sodium.
Who is the labeler?: Lannett Company, Inc., NDC labeler code 0527. 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?: 3 other product NDCs are listed under this name. See all Fluvastatin Sodium 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 Fluvastatin Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fluvastatin Sodium	Fluvastatin sodium 80 mg/1	Tablet, Film coated, Extended releaseOral	Teva Pharmaceuticals USA, Inc.	0093-7446	00093-7446-0100093-7446-56
Fluvastatin Sodiumfluvastatin	Fluvastatin sodium 20 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-8020	00378-8020-7700378-8020-93
Fluvastatin Sodiumfluvastatin	Fluvastatin sodium 40 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-8021	00378-8021-7700378-8021-93