Prescription drug · ANDA
Fluvastatin NDC 72162-1034
Fluvastatin sodium 40 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1034-1 | 72162103401 | 100 CAPSULE in 1 BOTTLE (72162-1034-1)Marketed from May 16, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- fluvastatin
- Active ingredients
- Fluvastatin sodium — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078407
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 72162-1034_ab031304-c267-4183-9378-39ec4728dbd9SPL ID ab031304-c267-4183-9378-39ec4728dbd9SPL set ID ccd6bbe1-e293-4e1c-9ec4-e6c217612e77RxCUI 310405UNII 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
N472162103401followed by a unit qualifier and the quantityPackage 72162-1034-01. 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 .
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 levels…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078407
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fluvastatin | Fluvastatin sodium 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8737 |
| Fluvastatin | Fluvastatin sodium 20 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8812 |
| Fluvastatin | Fluvastatin sodium 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2661 |
| Fluvastatin | Fluvastatin sodium 20 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-7442 |
| Fluvastatin | Fluvastatin sodium 40 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-7443 |
| Fluvastatin | Fluvastatin sodium 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2933 |