NDC codes

FDA NDC Directory
Product NDC (as listed)72865-151Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72865-0151Add 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
72865-151-30728650151307286501513030 TABLET, FILM COATED in 1 BOTTLE (72865-151-30)Marketed from Feb 16, 2021
72865-151-3172865015131728650151313 BLISTER PACK in 1 CARTON (72865-151-31) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 16, 2021

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)
Cinacalcet
Generic name (nonproprietary)
cinacalcet
Active ingredients
Cinacalcet hydrochloride — 60 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
XLCare Pharmaceuticals Inc.NDC labeler code 72865
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209403
Marketing start
Listing expires
Other FDA classes
Increased Calcium-sensing Receptor Sensitivity (Mechanism)
Identifiers
Product ID 72865-151_f26f3bd0-cfac-0d57-e053-2995a90aa96aSPL ID f26f3bd0-cfac-0d57-e053-2995a90aa96aSPL set ID ff0b9500-085a-4e1e-a2e4-fd918ed70b2eRxCUI 432400, 432401, 432402UNII 1K860WSG25UPC 0372865152300, 0372865151303, 0372865150306
Pharmacologic class
Calcium-sensing Receptor Agonist

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

N472865015130 followed by a unit qualifier and the quantity

Package 72865-0151-30. 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)

Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: • Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis • Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) • Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. ( 1.3 ) 1.1 Secondary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72865-151

What is NDC 72865-151?
72865-151 is the product NDC for Cinacalcet, Cinacalcet hydrochloride 60 mg/1 tablet, film coated, listed with the FDA by XLCare Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cinacalcet.
What is the active ingredient?
Cinacalcet hydrochloride.
Who is the labeler?
XLCare Pharmaceuticals Inc., NDC labeler code 72865. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cinacalcet?
44 other product NDCs are listed under this name. See all Cinacalcet 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 Cinacalcet NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CinacalcetCinacalcet hydrochloride 30 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-461570518-4615-00
CinacalcetCinacalcet hydrochloride 30 mg/1Tablet, Film coatedOralAurobindo Pharma Limited84386-11184386-0111-0184386-0111-0584386-0111-30+1 more
CinacalcetCinacalcet hydrochloride 60 mg/1Tablet, Film coatedOralAurobindo Pharma Limited84386-11284386-0112-0184386-0112-0584386-0112-30+1 more
CinacalcetCinacalcet hydrochloride 90 mg/1Tablet, Film coatedOralAurobindo Pharma Limited84386-11384386-0113-0184386-0113-0584386-0113-30+1 more
CinacalcetCinacalcet hydrochloride 30 mg/1Tablet, Film coatedOralAvPAK50268-18850268-0188-12
CinacalcetCinacalcet hydrochloride 30 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-51660687-0516-21
CinacalcetCinacalcet hydrochloride 30 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-750200904-7502-04
CinacalcetCinacalcet hydrochloride 30 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-15072865-0150-3072865-0150-31
CinacalcetCinacalcet hydrochloride 90 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-15272865-0152-3072865-0152-31
CinacalcetCinacalcet hydrochloride 30 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-10331722-0103-3031722-0103-31

All 45 Cinacalcet NDCs

Other NDCs under ANDA 209403

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

FDA NDC Directory listings under ANDA 209403
ProductStrengthForm · routeLabelerProduct NDC
CinacalcetCinacalcet hydrochloride 30 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-103
CinacalcetCinacalcet hydrochloride 60 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-104
CinacalcetCinacalcet hydrochloride 90 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-105
CinacalcetCinacalcet hydrochloride 30 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-150
CinacalcetCinacalcet hydrochloride 90 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-152

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