What is NDC 69097-948?

69097-948 is the product NDC for Capecitabine, Capecitabine 500 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Capecitabine NDC 69097-948 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-948Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0948Add 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
69097-948-08	6909709480869097094808	120 TABLET, FILM COATED in 1 BOTTLE (69097-948-08)Marketed from Jul 1, 2023

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: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209365
Marketing start: Jul 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 69097-948_c1549b67-948e-402d-9ba4-6fc16237df8fSPL ID c1549b67-948e-402d-9ba4-6fc16237df8fSPL set ID 2871c37d-5e55-437b-a434-fc86d845492aRxCUI 200327, 200328UNII 6804DJ8Z9UUPC 0369097949037
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

N469097094808 followed by a unit qualifier and the quantity

Package 69097-0948-08. 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 Jun 6, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Capecitabine is a nucleoside metabolic inhibitor with antineoplastic activity indicated for: • Adjuvant Colon Cancer ( 1.1 ) – Patients with Dukes' C colon cancer • Metastatic Colorectal Cancer ( 1.1 ) – First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred • Metastatic Breast Cancer ( 1.2 ) – In combination with docetaxel after failure of prior anthracycline-containing therapy – As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen 1.1 Colorectal Cancer Capecitabine tablets USP is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-948

What is NDC 69097-948?: 69097-948 is the product NDC for Capecitabine, Capecitabine 500 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, 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?: Cipla USA Inc., NDC labeler code 69097. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	CivicaScript LLC	82249-207	82249-0207-60
Capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	CivicaScript LLC	82249-210	82249-0210-12
Capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-644	68001-0644-07
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-643	68001-0643-06
capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-303	72603-0303-01
capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-774	31722-0774-60
capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-775	31722-0775-1231722-0775-60
Capecitabine	Capecitabine 500 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-112	82009-0112-12
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-949	69097-0949-03
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	Teyro Labs Private Limited	82511-001	82511-0001-15

All 31 Capecitabine NDCs

Other NDCs under ANDA 209365

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

FDA NDC Directory listings under ANDA 209365
Product	Strength	Form · route	Labeler	Product NDC
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-949
Capecitabine	Capecitabine 150 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-006
Capecitabine	Capecitabine 500 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-007