Prescription drug · ANDA
Fluvastatin NDC 0093-7443
Fluvastatin sodium 40 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-7443-01 | 0009374430100093744301 | 100 CAPSULE in 1 BOTTLE (0093-7443-01)Marketed from Jul 10, 2012 | |
| 0093-7443-56 | 0009374435600093744356 | 30 CAPSULE in 1 BOTTLE (0093-7443-56)Marketed from Jul 5, 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
- Generic name (nonproprietary)
- fluvastatin
- Active ingredients
- Fluvastatin sodium — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- 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 0093-7443_1fb50b66-e9d0-4fd1-928e-b37c4fff4cccSPL ID 1fb50b66-e9d0-4fd1-928e-b37c4fff4cccSPL set ID aad8b373-0aec-4efb-8e61-3d8114b31127RxCUI 310404, 310405UNII PYF7O1FV7FUPC 0300937443568, 0300937442561
- 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
N400093744301followed by a unit qualifier and the quantityPackage 00093-7443-01. 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.
About NDC 0093-7443
- What is NDC 0093-7443?
- 0093-7443 is the product NDC for Fluvastatin, Fluvastatin sodium 40 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluvastatin.
- What is the active ingredient?
- Fluvastatin sodium.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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?
- 6 other product NDCs are listed under this name. See all Fluvastatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluvastatin 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 | Fluvastatin sodium 20 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-7442 | 00093-7442-0100093-7442-56 |
| Fluvastatin | Fluvastatin sodium 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8737 | 63629-8737-01 |
| Fluvastatin | Fluvastatin sodium 20 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8812 | 63629-8812-01 |
| Fluvastatin | Fluvastatin sodium 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2661 | 71335-2661-01 |
| Fluvastatin | Fluvastatin sodium 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2933 | 71335-2933-01 |
| Fluvastatin | Fluvastatin sodium 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1034 | 72162-1034-01 |
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 20 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-7442 |
| 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 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2933 |
| Fluvastatin | Fluvastatin sodium 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1034 |