Prescription drug · ANDA
Fluvastatin Sodium (Fluvastatin) NDC 0378-8021
Fluvastatin sodium 40 mg/1 · Capsule · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-8021-77 | 0037880217700378802177 | 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-77)Marketed from Apr 11, 2012 | |
| 0378-8021-93 | 0037880219300378802193 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-93)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 — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090595
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 0378-8021_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
N400378802177followed by a unit qualifier and the quantityPackage 00378-8021-77. 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 .
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.
About NDC 0378-8021
- What is NDC 0378-8021?
- 0378-8021 is the product NDC for Fluvastatin Sodium (fluvastatin), Fluvastatin sodium 40 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluvastatin Sodium (Fluvastatin).
- What is the active ingredient?
- Fluvastatin sodium.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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.
Related NDCs: other Fluvastatin Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluvastatin Sodium | Fluvastatin sodium 80 mg/1 | Tablet, Film coated, Extended releaseOral | Lannett Company, Inc. | 0527-2580 | 00527-2580-3200527-2580-37 |
| 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 |
Other NDCs under ANDA 090595
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 Sodiumfluvastatin | Fluvastatin sodium 20 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-8020 |