NDC codes

FDA NDC Directory
Product NDC (as listed)31722-775Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0775Add 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
31722-775-123172207751231722077512120 TABLET, FILM COATED in 1 BOTTLE (31722-775-12)Marketed from Mar 5, 2024
31722-775-60317220775603172207756060 TABLET, FILM COATED in 1 BOTTLE (31722-775-60)Marketed from Apr 19, 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)
capecitabine
Generic name (nonproprietary)
capecitabine
Active ingredients
Capecitabine — 500 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 210203
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 31722-775_519e85b4-ff10-917f-e063-6394a90a12dfSPL ID 519e85b4-ff10-917f-e063-6394a90a12dfSPL set ID 3e7d6317-1439-4976-ae00-6f62619ec3ddRxCUI 200327, 200328UNII 6804DJ8Z9UUPC 0331722775601, 0331722774604
Pharmacologic class
Nucleoside Metabolic 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

N431722077512 followed by a unit qualifier and the quantity

Package 31722-0775-12. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Capecitabine is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer • adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) • perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. ( 1.1 ) • treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) Breast Cancer • treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline-or taxane-containing chemotherapy is not indicated. ( 1.2 ) • treatment of patient…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-775

What is NDC 31722-775?
31722-775 is the product NDC for capecitabine, Capecitabine 500 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
capecitabine.
What is the active ingredient?
Capecitabine.
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 capecitabine?
30 other product NDCs are listed under this name. See all capecitabine 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 capecitabine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralCivicaScript LLC82249-20782249-0207-60
CapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralCivicaScript LLC82249-21082249-0210-12
CapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-64468001-0644-07
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-64368001-0643-06
capecitabineCapecitabine 500 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-30372603-0303-01
capecitabineCapecitabine 150 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-77431722-0774-60
CapecitabineCapecitabine 500 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-11282009-0112-12
CapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralCipla USA Inc.69097-94869097-0948-08
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralCipla USA Inc.69097-94969097-0949-03
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralTeyro Labs Private Limited82511-00182511-0001-15

All 31 capecitabine NDCs

Other NDCs under ANDA 210203

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

FDA NDC Directory listings under ANDA 210203
ProductStrengthForm · routeLabelerProduct NDC
capecitabineCapecitabine 150 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-774
CapecitabineCapecitabine 150 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-643
CapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-644
capecitabineCapecitabine 500 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-303

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in