What is NDC 31722-876?

31722-876 is the product NDC for pitavastatin calcium, Pitavastatin calcium 2.09 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

pitavastatin calcium NDC 31722-876

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-876Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0876Add 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 NDC	11-digit (billing)	Package	Copy
31722-876-90	3172208769031722087690	90 TABLET, FILM COATED in 1 BOTTLE (31722-876-90)Marketed from Apr 30, 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 — 2.09 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205977
Marketing start: Apr 30, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 31722-876_179e2267-daf5-1cab-e063-6394a90a7f0eSPL ID 179e2267-daf5-1cab-e063-6394a90a7f0eSPL set ID e9622824-cee5-49d7-9273-f18b9cc176fdRxCUI 861643, 861648, 861652UNII IYD54XEG3WUPC 0331722875905, 0331722876902, 0331722877909
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

N431722087690 followed by a unit qualifier and the quantity

Package 31722-0876-90. 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 May 4, 2024.

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 31722-876

What is NDC 31722-876?: 31722-876 is the product NDC for pitavastatin calcium, Pitavastatin calcium 2.09 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. 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?: Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
pitavastatin calcium	Pitavastatin calcium 1 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-291	72865-0291-90
pitavastatin calcium	Pitavastatin calcium 2 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-292	72865-0292-90
pitavastatin calcium	Pitavastatin calcium 4 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-293	72865-0293-90
pitavastatin calcium	Pitavastatin calcium 2.09 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-479	72603-0479-01
pitavastatin calcium	Pitavastatin calcium 4.18 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-480	72603-0480-01
pitavastatin calcium	Pitavastatin calcium 1.045 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-875	31722-0875-90
pitavastatin calcium	Pitavastatin calcium 4.18 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-877	31722-0877-90
Pitavastatin Calciumpitavastatin	Pitavastatin calcium 1 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5055	00378-5055-77
Pitavastatin Calciumpitavastatin	Pitavastatin calcium 2 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5056	00378-5056-77
Pitavastatin Calciumpitavastatin	Pitavastatin calcium 4 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5057	00378-5057-77

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
Product	Strength	Form · route	Labeler	Product NDC
pitavastatin calcium	Pitavastatin calcium 1.045 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-875
pitavastatin calcium	Pitavastatin calcium 4.18 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-877
pitavastatin calcium	Pitavastatin calcium 2.09 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-479
pitavastatin calcium	Pitavastatin calcium 4.18 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-480
pitavastatin calcium	Pitavastatin calcium 1 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-291
pitavastatin calcium	Pitavastatin calcium 2 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-292
pitavastatin calcium	Pitavastatin calcium 4 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-293