NDC codes

FDA NDC Directory
Product NDC (as listed)0093-7443Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-7443Add 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 NDC11-digit (billing)PackageCopy
0093-7443-010009374430100093744301100 CAPSULE in 1 BOTTLE (0093-7443-01)Marketed from Jul 10, 2012
0093-7443-56000937443560009374435630 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

N400093744301 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluvastatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FluvastatinFluvastatin sodium 20 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-744200093-7442-0100093-7442-56
FluvastatinFluvastatin sodium 40 mg/1CapsuleOralBryant Ranch Prepack63629-873763629-8737-01
FluvastatinFluvastatin sodium 20 mg/1CapsuleOralBryant Ranch Prepack63629-881263629-8812-01
FluvastatinFluvastatin sodium 40 mg/1CapsuleOralBryant Ranch Prepack71335-266171335-2661-01
FluvastatinFluvastatin sodium 40 mg/1CapsuleOralBryant Ranch Prepack71335-293371335-2933-01
FluvastatinFluvastatin sodium 40 mg/1CapsuleOralBryant Ranch Prepack72162-103472162-1034-01

Other NDCs under ANDA 078407

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

FDA NDC Directory listings under ANDA 078407
ProductStrengthForm · routeLabelerProduct NDC
FluvastatinFluvastatin sodium 20 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-7442
FluvastatinFluvastatin sodium 40 mg/1CapsuleOralBryant Ranch Prepack63629-8737
FluvastatinFluvastatin sodium 20 mg/1CapsuleOralBryant Ranch Prepack63629-8812
FluvastatinFluvastatin sodium 40 mg/1CapsuleOralBryant Ranch Prepack71335-2661
FluvastatinFluvastatin sodium 40 mg/1CapsuleOralBryant Ranch Prepack71335-2933
FluvastatinFluvastatin sodium 40 mg/1CapsuleOralBryant Ranch Prepack72162-1034

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