Gefitinib NDC 0480-4053

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-4053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-4053Add 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
0480-4053-56	00480405356	30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56)Marketed from Jun 21, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Gefitinib
Generic name (nonproprietary): gefitinib
Active ingredients: Gefitinib — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Teva Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208913
Marketing start: Jun 21, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0480-4053_07edf73f-2a64-479f-9eb3-08747a9d11bbSPL ID 07edf73f-2a64-479f-9eb3-08747a9d11bbSPL set ID 3dd135f0-5db1-4236-9756-04533b66dc9dRxCUI 349472UNII S65743JHBSUPC 0304804053560
Pharmacologic class: Kinase 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

N400480405356 followed by a unit qualifier and the quantity

Package 00480-4053-56. 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 Feb 1, 2022.

Indications (excerpt from the label)

Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14 ) ] . Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14) ] . Gefitinib tablets are a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lun…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)