Fluvastatin Sodium (fluvastatin) NDC 0378-8020

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8020Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8020Add 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
0378-8020-77	00378802077	90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-77)Marketed from Apr 11, 2012
0378-8020-93	00378802093	30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-93)Marketed from Apr 11, 2012

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
Active ingredients: Fluvastatin sodium — 20 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090595
Marketing start: Apr 11, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 0378-8020_f31c30b0-95b9-47d4-8ef8-f6fa51a2e5b9SPL ID f31c30b0-95b9-47d4-8ef8-f6fa51a2e5b9SPL set ID d0a7247c-5d83-4bc1-840f-c58314d14195RxCUI 310404, 310405UNII PYF7O1FV7FUPC 0303788021930, 0303788020933
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

N400378802077 followed by a unit qualifier and the quantity

Package 00378-8020-77. 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 Aug 20, 2020.

Indications (excerpt from the label)

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. Fluvastatin capsules are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia ( 1.1 ) • Reduce elevated TC, LDL-C, and Apo B le…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090595

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

FDA NDC Directory listings under ANDA 090595
Product	Strength	Form · route	Labeler	Product NDC
Fluvastatin Sodiumfluvastatin	Fluvastatin sodium 40 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-8021