NDC codes

FDA NDC Directory
Product NDC (as listed)72603-480Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72603-0480Add 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
72603-480-01726030480017260304800190 TABLET, FILM COATED in 1 BOTTLE (72603-480-01)Marketed from Dec 1, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
pitavastatin calcium
Generic name (nonproprietary)
pitavastatin calcium
Active ingredients
Pitavastatin calcium — 4.18 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
NorthStar RxLLCNDC labeler code 72603
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205977
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 72603-480_27e1ba97-23bf-fc12-e063-6394a90a1699SPL ID 27e1ba97-23bf-fc12-e063-6394a90a1699SPL set ID 98e3f1df-5b38-4169-a340-adb145eac459RxCUI 861648, 861652UNII IYD54XEG3W
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

N472603048001 followed by a unit qualifier and the quantity

Package 72603-0480-01. 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)

Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets are a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72603-480

What is NDC 72603-480?
72603-480 is the product NDC for pitavastatin calcium, Pitavastatin calcium 4.18 mg/1 tablet, film coated, listed with the FDA by NorthStar RxLLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
pitavastatin calcium.
What is the active ingredient?
Pitavastatin calcium.
Who is the labeler?
NorthStar RxLLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for pitavastatin calcium?
16 other product NDCs are listed under this name. See all pitavastatin calcium 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 pitavastatin calcium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
pitavastatin calciumPitavastatin calcium 1 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-29172865-0291-90
pitavastatin calciumPitavastatin calcium 2 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-29272865-0292-90
pitavastatin calciumPitavastatin calcium 4 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-29372865-0293-90
pitavastatin calciumPitavastatin calcium 2.09 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-47972603-0479-01
pitavastatin calciumPitavastatin calcium 1.045 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-87531722-0875-90
pitavastatin calciumPitavastatin calcium 2.09 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-87631722-0876-90
pitavastatin calciumPitavastatin calcium 4.18 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-87731722-0877-90
Pitavastatin CalciumpitavastatinPitavastatin calcium 1 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-505500378-5055-77
Pitavastatin CalciumpitavastatinPitavastatin calcium 2 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-505600378-5056-77
Pitavastatin CalciumpitavastatinPitavastatin calcium 4 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-505700378-5057-77

All 17 pitavastatin calcium NDCs

Other NDCs under ANDA 205977

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

FDA NDC Directory listings under ANDA 205977
ProductStrengthForm · routeLabelerProduct NDC
pitavastatin calciumPitavastatin calcium 1.045 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-875
pitavastatin calciumPitavastatin calcium 2.09 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-876
pitavastatin calciumPitavastatin calcium 4.18 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-877
pitavastatin calciumPitavastatin calcium 2.09 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-479
pitavastatin calciumPitavastatin calcium 1 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-291
pitavastatin calciumPitavastatin calcium 2 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-292
pitavastatin calciumPitavastatin calcium 4 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-293

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