NDC codes

FDA NDC Directory
Product NDC (as listed)72485-204Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72485-0204Add 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
72485-204-6072485020460724850204601 BOTTLE in 1 CARTON (72485-204-60) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 1, 2019

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 150mg
Generic name (nonproprietary)
capecitabine
Active ingredients
Capecitabine — 150 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Armas Pharmaceuticals Inc.NDC labeler code 72485
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207456
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 72485-204_680dac89-d210-4eb8-a955-bf40e652c546SPL ID 680dac89-d210-4eb8-a955-bf40e652c546SPL set ID 7f555b6b-60db-45e2-a61e-537e57f43fdcRxCUI 200327UNII 6804DJ8Z9U
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

N472485020460 followed by a unit qualifier and the quantity

Package 72485-0204-60. 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 tablets are 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 are 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 72485-204

What is NDC 72485-204?
72485-204 is the product NDC for Capecitabine 150mg (capecitabine), Capecitabine 150 mg/1 tablet, film coated, listed with the FDA by Armas Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Capecitabine 150mg (Capecitabine).
What is the active ingredient?
Capecitabine.
Who is the labeler?
Armas Pharmaceuticals Inc., NDC labeler code 72485. 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 150mg?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 207456

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

FDA NDC Directory listings under ANDA 207456
ProductStrengthForm · routeLabelerProduct NDC
Capecitabine 500mgcapecitabineCapecitabine 500 mg/1Tablet, Film coatedOralArmas Pharmaceuticals Inc.72485-205

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